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IMPLANT SYSTEMS · PEDICLE SCREW DIRECTORY

Recap a system before the case

Where manufacturers publish the instructions for use and surgical technique guides for their thoracolumbar pedicle screw systems — for surgeons, scrub teams and theatre staff who need a quick refresher on an unfamiliar set. We feature 13 of the manufacturers in detail, chosen by the editors as the global majors plus European mid-size makers widely used in Europe and the US, and a searchable worldwide table covers 168 more — 181 manufacturers in all — plus growth-friendly and growth-modulating systems for the young spine, artificial disc and nucleus replacement, spine endoscopy and retractor systems.

13 featured manufacturers181 in the worldwide databaseIFUs and technique guidesEnglish first, regional editions markedIndependent · no paid listings

Conflicts of interest: Spinal Frontiers is published by NSpine, whose courses are supported by medical device companies, including some listed here. Support has no influence on what we list or how. See About.

DOCUMENT 1

Instructions for use (IFU)

The regulatory package insert: indications, contraindications, warnings, materials, MRI information and reprocessing. Usually public on the manufacturer's eIFU portal, searchable by system, country and language.

DOCUMENT 2

Surgical technique guide

The practical walk-through: instrument sequence, screw insertion, rod reduction and final locking. Several manufacturers publish theirs openly; others provide them only through the sales representative. We link only the manufacturer’s own edition, or a copy published by a regulator such as the FDA. Where none is public, we link the manufacturer’s request or contact page.

ALWAYS CHECK

This directory is for recap and orientation only. The IFU supplied with the set, or the current eIFU for your country and lot, always takes precedence. Technique guides are revised less often than IFUs and can lag behind the current instruments — if your set does not match the guide, ask the representative before the case. Indications and components can differ between the EU and the US.

REGULATOR COPY

Links marked this way open a manufacturer’s document as published by a regulator, such as the US FDA, rather than by the manufacturer. It may not be the current edition or apply to your country. If you find a link that is outdated or wrong, please tell us at spinalfrontiers@nspine.com and we will correct or remove it.

WHO MAKES IT NOW?

Recent ownership changes

Familiar systems may now carry a different company name on the label — and older technique guides may still show the previous one.

Stryker → VB SpineUS spinal implants (Xia, ES2, Mantis) sold April 2025; other countries transfer later, so EU labels may still read Stryker.
ZimVie → Highridge MedicalThe former Zimmer Biomet spine business, sold and renamed in April 2024. Vital now ships under Highridge.
NuVasive → Globus MedicalMerged in 2023. NuVasive IFUs, such as Reline, remain on their own eIFU site.
SeaSpine → OrthofixMerger completed January 2023.

Manufacturers and systems (13)

THE DIRECTORY · A–Z

13 manufacturers, listed alphabetically. A selection, not exhaustive. Under each technique guide we show its region, language and, where printed, its revision. Solid buttons are the manufacturer’s own documents; dashed buttons are copies published by a regulator.

Aesculap (B. Braun)

Germany
SYSTEMSS4 Spinal System · S4 Element (open and MIS) · Ennovate Thoracolumbar & Sacropelvic
Instructions for use and technique guides
INSTRUCTIONS FOR USEB. Braun eIFU portal, as printed on Aesculap S4 labelling. Search by article number.
SURGICAL TECHNIQUE GUIDEB. Braun hosts operative-technique PDFs in its own product catalogue. The S4 open technique is published in German only.
S4 Spinal System – Operationstechnik (open) →Germany · German · c. 2014 edition
S4 Element MIS – surgical manual →B. Braun Germany · English title
English technique via rep

ATEC (Alphatec Spine)

USA
SYSTEMSInvictus · Arsenal · Illico MIS
Instructions for use and technique guides
INSTRUCTIONS FOR USESearch by system name, then filter by country and by category (Posterior Fixation). US and international IFUs listed separately.
SURGICAL TECHNIQUE GUIDEATEC does not publish its technique guides. Request the current edition through ATEC’s contact form.
Region-specific versionsTechnique on requestCheck EU availability

Globus Medical

USA
SYSTEMSCREO Stabilization System
Instructions for use and technique guides
INSTRUCTIONS FOR USEEnglish (US) and OUS (outside-US) device inserts are listed separately. A paper copy can be requested.
SURGICAL TECHNIQUE GUIDEGlobus’s public technique-guide library holds no CREO guides. Ask your Globus representative or use the contact page for the current edition.
Region-specific versionsTechnique on request

Globus Medical — NuVasive systems

USA
Formerly NuVasive (merged 2023)
SYSTEMSReline (open and MAS/MIS)
Instructions for use and technique guides
INSTRUCTIONS FOR USEChoose region, product and language. Cleaning and disassembly instructions for Reline instruments are listed separately.
SURGICAL TECHNIQUE GUIDENo Reline technique guide is published on the Globus or NuVasive sites. Ask your representative or use the contact page for the current edition.
Region-specific versionsTechnique on request

Highridge Medical

USA
Formerly ZimVie / Zimmer Biomet spine
SYSTEMSVital Spinal Fixation System
Instructions for use and technique guides
INSTRUCTIONS FOR USEHighridge’s electronic labelling portal, linked from its website; a "request a document" option is available.
SURGICAL TECHNIQUE GUIDEHighridge hosts the Vital technique guide on its own site. The file is still the 2018 Zimmer Biomet edition, so ask your representative whether a newer revision exists.
Vital – degenerative thoracolumbar →Global · English · 2018 edition
Older technique edition

J&J MedTech (DePuy Synthes)

USA / Switzerland
SYSTEMSEXPEDIUM · EXPEDIUM VERSE (open) · VIPER 2 · VIPER PRIME (MIS)
Instructions for use and technique guides
INSTRUCTIONS FOR USEChoose "Healthcare Professional" and your language. Previous IFU versions can be selected.
SURGICAL TECHNIQUE GUIDEJ&J publishes the full technique guide for the VIPER Cortical Fix fenestrated screws, a summarised operative-steps page for VIPER PRIME (not full instructions), and surgeon technique videos through the J&J Institute. Full EXPEDIUM and VIPER 2 manuals come from the sales representative.
VIPER PRIME – operative steps →US · English · summary
Thoracolumbar deformity – J&J Institute →US · English · videos incl. EXPEDIUM VERSE
HCP gateFull manuals on request

Medacta

Switzerland
SYSTEMSM.U.S.T. Pedicle Screw System
Instructions for use and technique guides
INSTRUCTIONS FOR USEMedacta’s IFU search: filter by country, business unit (Spine) and product.
SURGICAL TECHNIQUE GUIDEMedacta publishes its surgical techniques openly. The main English edition is not for the US market; separate US editions exist for some components.
M.U.S.T. surgical technique →Outside the US · English · Rev 12 (2020)
M.U.S.T. reduction screws →US edition · English
Region-specific versions

Medtronic

USA / Ireland
SYSTEMSCD HORIZON SOLERA (incl. Voyager and MIS options)
Instructions for use and technique guides
INSTRUCTIONS FOR USEMedtronic Manual Library: select your region first. Previous versions of manuals are available.
SURGICAL TECHNIQUE GUIDETechnique content is offered through Medtronic Academy, which may require registration. One English technique, for a specific procedure, is public on Medtronic’s European site; the full SOLERA technique comes from the representative.
Medtronic Academy – posterior thoracolumbar →US · English · access to confirm
HCP gateRegion-specific versions

Orthofix

USA / Italy
⚠ Recall 19 Aug: Mariner Deformity Extended Polyaxial Head →Incl. SeaSpine (merged 2023)
SYSTEMSFirebird · Firebird NXG (open) · Phoenix MIS
Instructions for use and technique guides
INSTRUCTIONS FOR USESeparate US and international IFU pages; the international page holds EU MDR supplemental IFUs in several languages.
SURGICAL TECHNIQUE GUIDEOrthofix publishes the Firebird NXG operative technique openly. For Firebird and Phoenix, the IFU says operative techniques are available on request from Orthofix; we found no reliable copy elsewhere.
Firebird NXG – operative technique →US edition · English · Rev AC (2024)
Region-specific versionsPhoenix technique on request

SIGNUS Medizintechnik

Germany
SYSTEMSDIPLOMAT · CONKLUSION
Instructions for use and technique guides
INSTRUCTIONS FOR USEChoose country and language. Separate areas for Germany (German), International (English, not USA) and USA.
SURGICAL TECHNIQUE GUIDESIGNUS does not publish its technique guides. For the full technique, ask SIGNUS (info@signus.com).
Region-specific versionsTechnique on request

Spineart

Switzerland
SYSTEMSROMEO 2 · PERLA TL
Instructions for use and technique guides
INSTRUCTIONS FOR USEWe found no public IFU portal; IFUs are available from Spineart on request.
SURGICAL TECHNIQUE GUIDENo technique guide is published on spineart.com; Spineart provides the full handbook on request.
IFU on requestTechnique on request

Stryker / VB Spine

USA / France
US business now VB Spine (2025)
SYSTEMSXia 3 · Xia 4.5 · ES2 (MIS) · Mantis
Instructions for use and technique guides
INSTRUCTIONS FOR USEStryker eIFU covers the systems; a "request a document" option is available. US products are also listed on VB Spine’s IFU site.
SURGICAL TECHNIQUE GUIDEStryker does not publish its spine technique guides; the IFU says they come from the representative.
Technique on requestOwnership differs by country

ulrich medical

Germany
SYSTEMSMomentum · Momentum MIS
Instructions for use and technique guides
INSTRUCTIONS FOR USEulrich’s eIFU portal, as printed on its labelling; a "request a document" option is available.
SURGICAL TECHNIQUE GUIDENo technique guide is published openly, and we found no copy elsewhere; ulrich’s US downloads page holds product brochures only. Available from the representative.
Technique via rep

Every pedicle screw maker in our directory (169)

MORE MANUFACTURERS · A–Z

The companies in our worldwide manufacturer directory that make thoracolumbar pedicle screw systems, beyond those above. Many smaller makers publish neither their IFU nor their technique guide online; where we found nothing, the row says so and links the manufacturer’s own contact or request page, plus a published company email where there is one. Solid links are the manufacturer’s own; dashed links are copies published by a regulator.

168 of 168 companies shown · 14 with at least one technique guide link

COMPANYPEDICLE SCREW SYSTEMSIFUTECHNIQUE GUIDE
A-SPINE
Taiwan
aspine.com.tw
SmartLoc Omega; SmartLoc Evolution; SmartMIS (open/MIS); ASA Spinal Fixation System
Product pages also link IFU and brochure PDFs; SmartMIS open technique: SmartMIS-Open-ST-HE.pdf.
IFUs →
eIFU table: find product row, click Download for the current IFU version PDF · English; Traditional/Simplified
Aditus Medical
Germany
aditus-medical.de
Aditus Spinal Stabilization System (U-shaped)
Polyaxial/monoaxial cannulated screw-rod system listed under thoracolumbar; also dynamic rod/plate systems.
IFUs →
eIFU request page: email qm@aditus-medical.de with product name/ref/UDI-DI
No technique guide published online
Aero Medical
Turkey
aerospine.com
Aerospine Posterior Spinal System (mono/polyaxial, cannulated, reduction screws)
Only an e-catalogue PDF (aerospine.com/documents/Aerospine-2026-21-e-catalog-tm.pdf); no IFU or technique online.
Ask the manufacturerNo technique guide published online
ALLUMIN8
USA
allumin8.com
A8 INTEGR8 Porous Pedicle Screw System
3D-printed porous pedicle screw; no public IFU or technique guide found yet.
Ask the manufacturerNo technique guide published online
American Implant
Argentina
—
Argentine trade catalogue lists pedicle screws. no website or system name found.
Ask the manufacturerNo technique guide published online
ARTFX Medical
USA
artfxmed.com
VANGUARDFX; SPEEDIUM; MISTOWER; ADURA (fenestrated)
Only a bilingual product catalogue (no surgical steps) found: artfxmed.com/wp-content/uploads/2023/04/ARTFX-Spine.pdf
Ask the manufacturerNo technique guide published online
Astura Medical
USA
asturamedical.com
OLYMPIC; OLYMPIC MIS; OLYMPIC Deformity; MASADA / MASADA MIS
Manufacturer product pages host no documents; IFU and technique guide on request.
Ask the manufacturerNo technique guide found online · on request (manufacturer site has 'Request Information' forms only)
Auxein Medical
India
auxein.com
VERTAUX 5.5mm Pedicle Screw System; VERTAUX Basico Polyaxial Screw
FDA K201457 for VERTAUX 5.5. Technique PDFs linked from product pages.
IFUs →
Open product page, IFU section: Spinal Screw System sterile/non-sterile PDFs (central list at /ifu-report/ is
Back 2 Basics Direct
USA
Dymaxeon (6.0 pedicle screw)
System known only from FDA GUDID entries (labeler Back 2 Basic Direct, LLC); no website found.
Ask the manufacturerNo technique guide published online
BAUI
Taiwan
baui.com.tw (link removed: site currently unreliable)
NOVA Minimally Invasive System; Facilis Spinal System
Baui Biotech; FDA 510(k) K182416/K242899 (NOVA), K191494 (Facilis). Site lists no documents.
Ask the manufacturerNo technique guide published online
Beijing Chunlizhengda Medical (Chunli)
China
clzd.com
Posterior spinal internal fixation system (minimally invasive); iliac spinal internal fixation system
Chinese-language product pages only (no English names); no downloads. Mainly joints/trauma maker.
Ask the manufacturerNo technique guide published online
Beijing Keyi Medical Device Technology
China
keyibangen.com
KeYi Spinal Fixation System
System known from FDA 510(k) K190567 (2019); no official website found.
Ask the manufacturerNo technique guide published online
Beijing Weigao Yahua
China
YAHUA Spinal System
Beijing Weigao Yahua Artificial Joint Development; FDA K152324 (2016). No website or documents found.
Ask the manufacturerNo technique guide published online
Biedermann Motech
Germany
biedermann.com
MOSS VRS; MOSS VRS MIS; MOSS Modularity
Established maker; contact service@biedermann.com for IFU/technique guides until site returns.
Ask the manufacturerNo technique guide published online
Biomecanica Group
Brazil
biomecanica.com.br
—Ask the manufacturerNo technique guide published online
Biomech Spine (Paonan Biotech)
Taiwan
paonan.com.tw
Trend II; Trend MIS II; Bone Cement Screw; Armstrong Posterior Spinal Fixation System
product pages not checked for downloads. FDA K161225. Armstrong.
Ask the manufacturerNo technique guide published online
BK Meditech
South Korea
MEGA PLUS MIS Spine System; DVX 5.5 Spine System
Systems from FDA GUDID/510(k) (K090424); website not found.
Ask the manufacturerNo technique guide published online
Black Box Medical
USA
FUSE Pedicle Screw System; Stowe Pedicle Screw System
Systems from FDA 510(k) K182283, K181554; see Evolution Spine row for Stowe IFU.
Ask the manufacturerNo technique guide published online
BM Korea
South Korea
bmkmedi.com
SYNSTER / SYNSTER PLUS Pedicle Screw System; Galaxy MIS Screw System
Systems from FDA GUDID.
Ask the manufacturerNo technique guide published online
Bonetech Medisys
India
bonetechmedisys.com
Magnifica FNC Pedicle Screw System
System seen only on Medical XPRT listing; no own website found.
Ask the manufacturerNo technique guide published online
BoxSPINE
USA
boxspine.com
DUET Spinal Fixation System (rodless)
Rodless halo-screw/sphere-screw construct, L1–S1; IFU does not call components pedicle screws.
IFUs →
Single PDF linked from the DUET product page · US · 918-0010 Rev A, Apr 2026
No technique guide published online
Captiva Spine
USA
captivaspine.com
CapLOX II; TowerLOX MIS; TowerLOX-EXT
Documents sit behind password-protected distributor downloads area; no public IFU/technique found.
Ask the manufacturerNo technique guide published online
CarboFix
Israel
carbofixspine.com
CarboClear X Pedicle Screw System; CarboClear Hybrid MIS Pedicle Screw System
Spine site carbofixspine.com; product page has brochure PDF only, technique via request form.
Ask the manufacturerNo technique guide published online
Changzhou Geasure Medical
China
Spinal Inner Fixation System
FDA K222031 (2022, NKB pedicle screw). No website or documents found.
Ask the manufacturerNo technique guide published online
Chanpin Medtak
Taiwan
cpmt.com.tw
ChanPin Pedicle Screw Spinal System
ChanPin MedTak Co., New Taipei; FDA K251251 (June 2026). No website found.
Ask the manufacturerNo technique guide published online
ChM sp. z o.o.
Poland
chm.eu
CHARSPINE2; CHARSPINE2 MIS; CHARSPINE2 VD; CHARSPINE (older)
Full technique library at chm.eu/en/do-pobrania/surgical-techniques/ behind HCP confirmation.
IFUs →
ChM e-IFU portal (JavaScript app); search for product/catalogue number
Clariance (Clariance Spinevision)
France
clariance-spinevision.com
Erisma-LP EVO; Erisma-LP MIS; Lumis (MIS); Ulis
Also Plus and Flex+2 posterior systems; no technique guides published online.
IFUs →
Browse product tree by brand (Clariance/Spinevision) and region, then product; PDF e-labels · EU, USA, Brazil,
No technique guide published online
Clover Orthopedics (Clover Next)
Italy
cloverorthopedics.com
Misano Spinal Stabilization System (Open and MIS)
Docs hosted on Google Drive linked from official product page; content not verified (file did not render).
Ask the manufacturer
CONMET
Russia
—
Moscow titanium implant maker. dental, CMF, spine. no named pedicle screw system or documents found.
Ask the manufacturerNo technique guide published online
CoreLink
USA
corelinksurgical.com
Tiger; Tiger 2; Tiger Deformity; Tiger Iliac
The IFU links on the company website were not working when we checked; ask the company for the current IFU.
IFUs →
IFU list by product (Tiger CL-FORM-090 Rev 12, Tiger 2 LBL-040 Rev 0) · US
No technique guide published online
Corentec
South Korea
corentec.com
LOSPA IS Spinal System
Mainly joints company; one pedicle screw system. No public IFU page found.
Ask the manufacturerNo technique guide published online
CTL Amedica (CTL Medical)
USA
ctlamedica.com
TAURUS; Preference 2; PICASSO II (MIS); FLEX (MIS)
Product pages offer brochures without surgical steps; technique guides not published.
IFUs →
One IFU covering the whole pedicle fixation platform; also linked from each product page · US · IFU.114.001G R
No technique guide published online
Demetra Holding
Italy
demetraholding.com
polyphem (open); GoPLF! (sterile-packed)
Holding (Tecres, GetSet Surgical etc.); GoPLF! sterile kit with videos only, no IFU/technique online.
Ask the manufacturerNo technique guide published online
Dio Medical
South Korea
Fixpine II System
System known only from 2010 FDA clearance.
Ask the manufacturerNo technique guide published online
Double Medical Technology
China
doublemedicalgp.com
Hobbit Spine 5.5/6.0; Hobbit MIS; Hobbit Spine 4.75; TINA Spine System
FDA K151458 Universal Spine System. Product subpages failed to load; no documents found.
Ask the manufacturerNo technique guide published online
EgiFix Medical
Egypt
egifix.com
Biaxial Toploading Screw; Percutaneous Screw
No technique guide listed; Spine Screws Catalogue also behind form.
IFUs →
Download page, IFU section: 'Non sterile spine screws system'; fill in contact form to receive file
No technique guide published online
Eminent Spine
USA
eminentspine.com
Pedicle Screw System (open); MIS Pedicle Screw System; 3D Titanium Pedicle Screw; Scoliosis Deformity
All manuals at eminentspine.com/surgical-technique-manuals/ incl. Scoliosis Deformity guide.
IFUs →
IFU list page; click 'Learn More' for each system's PDF · US
EUROS International
France
euros.fr
E.SPINE
E.SPINE thoraco-lumbo-sacral pedicle screw system; also NEMOST growth domino.
IFUs →
Single implant IFU PDF for E.SPINE, linked from products page (euros.fr/produits/#rachis) · French site
No technique guide published online
Evolution Spine
USA
evolutionspine.com
Stowe Pedicle Screw; Whistler Modular Pedicle Screw
Stowe originally cleared by Black Box Medical (K181554). Dallas TX.
IFUs →
'Electronic IFUs' list; each opens a PDF on the company's MasterControl portal · US
No technique guide published online
evospine
Germany
evospine.com
evospine MIS all-in-one screw (with BAMBOO single-use instruments)
Sterile single-packed MIS pedicle screws; no IFU or technique online.
Ask the manufacturerNo technique guide published online
FloSpine
USA
flospine.com
Canaveral Degenerative; Canaveral Modular; Canaveral Deformity; Canaveral MIS
Only brochures (no surgical steps) for Canaveral; no technique guide published.
IFUs →
Resources page; Canaveral Pedicle Screw System IFU PDF listed under IFUs · US
No technique guide published online
FRADIS Medical
France
fradis-medical.com
—
Site content not machine-readable; implant/instrument maker, spine systems unconfirmed.
Ask the manufacturerNo technique guide published online
G6 Spine
USA
g6spine.com
—Ask the manufacturerNo technique guide published online
GBS Commonwealth
South Korea
gbscommonwealth.com
Jasper; Jasper MIS
IFU covers Jasper open and MIS. No technique guide published.
IFUs →
IFU table by product: Jasper Spinal Fixation System row, download PDF (Korean list at /ifu/) · US (English) pa
No technique guide published online
Genesys Spine
USA
genesysspine.com
TiLock2 Spinal System; TiLock Modular; TiLock XT MIS
No public IFU or technique guide found on product pages.
Ask the manufacturerNo technique guide published online
GESCO
India
Denique Pedicle Screw System
GESCO Healthcare, Chennai; system name from B2USA trade hotsite only.
Ask the manufacturerNo technique guide published online
GetSet Surgical
Switzerland
getsetsurgical.com
GoPLF!
Sterile single-use kits. see Demetra GoPLF! page.
Ask the manufacturerNo technique guide published online
GPC Medical
India
gpcmedical.com
Single Lock mono/polyaxial pedicle screws (no system brand name)
Generic screw catalogue items; no IFU or technique online.
Ask the manufacturerNo technique guide published online
GRIPORTHO
India
griportho.com
Polyaxial pedicle screws (no system brand name)
Griportho Surgicals, Vadodara; IndiaMART listing only.
Ask the manufacturerNo technique guide published online
GS Medical
South Korea
gsmedicalusa.com
AnyPlus Pedicle Screw System; GSS Pedicle Screw System; AnyPlus MIS; AnyPlus Deformity
US site under development; documents not public. Also AnyPlus Fenestrated.
Ask the manufacturerNo technique guide published online
Hardmed
Egypt
hardmed-eg.com
—
Homepage mentions 'Pedicle Screw' generically; no system name or documents online.
Ask the manufacturerNo technique guide published online
HCM Orthocare
India
hcmorthocare.com
Single Lock mono/polyaxial screws (no system brand name)
Generic spine screws; no IFU or technique online.
Ask the manufacturerNo technique guide published online
Hipokrat
Turkey
hipokrat.com.tr
Aspendos Spinal Sistem; Aspendos Pediatrik Sistem
Thoracolumbar systems listed under Omurga; no documents online; contact info@hipokrat.com.tr.
Ask the manufacturerNo technique guide published online
Humantech (HumanTech Spine)
Germany
humantech-spine.de
VENUS; VENUS nano; VENUS mini 2.0
Only VENUS Fixation verified to contain OP-Technik; others unverified brochures.
IFUs →
IFU download page: PDFs grouped by product, current + archive · DE/EN
icotec
Switzerland
icotec-medical.com
VADER Pedicle System (CF/PEEK)
Carbon/PEEK VADER system; factsheet (German) online, no surgical technique published.
IFUs →
dokspot eIFU portal; select product/language
No technique guide published online
Indius Medical Technologies
India
indiusmedical.com
PINAK Stabilization System; AYUJ Stabilization System; ACURA Stabilization System (US)
PINAK confirmed as lumbar pedicle screw system; no documents online.
Ask the manufacturerNo technique guide published online
Ingenium Spine
USA
ingeniumspine.com
Ingenix Spinal System
Tempe, Arizona.
IFUs →
Single PDF linked from homepage · US · LBL-001 V5, 2024-07
Innosys
South Korea
innosys.co.kr
—Ask the manufacturerNo technique guide published online
Innovasis
⚠ Recall 3 Aug: Anti-torque instrument LS-749 →
USA
innovasis.com
Excella II; Excella III-D; Excella MIS
Product pages say inserts and technique guides are in Resources section; not verified.
Ask the manufacturerNo technique guide published online
Innovative Surgical Designs
USA
—Ask the manufacturerNo technique guide published online
Intelivation Technologies
USA
intelivationtech.com
Golden Isles Pedicle Screw System; Golden Isles MIS
Plymouth Meeting, PA; no public IFU/technique documents.
Ask the manufacturerNo technique guide published online
intromed
Germany
intromed.de
—Ask the manufacturerNo technique guide published online
Japan Medical Dynamic Marketing
Japan
jmdm.co.jp
Pagoda Spinal System; IBIS Spinal System
Pedicle screw status of Pagoda/IBIS not confirmed; documents behind HCP login.
Ask the manufacturerNo technique guide published online
Jayon Implants
India
jayonimplants.com
MONOLOCK; MONOLOCK ULTRA; MONOLOCK DEFORMITY; MONOLOCK MIS
SSCP also posted. No technique guide online.
IFUs →
Single IFU PDF linked from Thoraco Lumbar Spinal Fixation System page · English
No technique guide published online
Jiangsu IDEAL Medical
China
Ideal Pedicle Screw Spinal SystemAsk the manufacturerNo technique guide published online
Jiangsu Trauhui Medical
China
—Ask the manufacturerNo technique guide published online
Kalitec Medical
USA
kalitecmed.com
Nido; CosmoLock MIS
Sarasota FL; Nido brochure Rev B 12/2025 has no surgical steps.
Ask the manufacturerNo technique guide published online
KYOCERA Medical
Japan
medical.kyocera.com
S100 Pedicle Screw System
Sold via US subsidiary KYOCERA Medical Technologies; Japanese site has no spine documents.
IFUs →
Resource Library: Spine section, S100 Pedicle Screw System IFU PDF · US (KYOCERA Medical Technologies)
No technique guide published online
Kyocera Medical Technologies
USA
kyocera-medical.com
S100 Pedicle Screw System; Monaco HA
Formerly Renovis; no Monaco HA IFU listed.
IFUs →
IFU Library grouped by category; S100 Pedicle IFU under Spine · US (separate Australia section)
No technique guide published online
L&K Biomed / L&K Spine
South Korea
lnkbiomed.com
AccelFix-S; OpenLoc-L
MIS category not checked. No documents on product pages.
Ask the manufacturerNo technique guide published online
LfC
Poland
lfc.com.pl
DERO Spinal System
DERO is a broad spinal system; pedicle screw component inferred, technique guides not found online.
IFUs →
IFU page: general DERO IFU PDF in EN/DE/FR/IT/PL; paper copy free on request · EN/DE/FR/IT/PL
No technique guide published online
Life Spine
USA
lifespine.com
ARx; CENTERLINE
No public IFU or technique PDFs; documents likely on distributor OneHub portal.
Ask the manufacturerNo technique guide published online
Madison Ortho
USA
madisonortho.com
NEPTUNE 5.5 Degenerative; NEPTUNE 5.5 MIS; SATURN
Offices in Puerto Rico, Florida, Latin America, Asia.
Ask the manufacturerNo technique guide published online
Matrix Meditec
India
matrixmeditec.com
Dorso-lumbar mono/polyaxial and fenestrated pedicle screws (no system brand name)
No IFU or technique online.
Ask the manufacturerNo technique guide published online
Medynus
USA
medynus.com
Open Pedicle Screw; Extended Arm Screw System
Irvine CA with Korea branch; no documents published.
Ask the manufacturerNo technique guide published online
Medyssey
South Korea
medyssey.com
ILIAD; ZENIUS; KORA; ARTeMIS
Thoracolumbar line: ARTeMIS, HEDJET, ILIAD, KORA, ZENIUS (FDA K131878). No technique guide published by the manufacturer.
Ask the manufacturerNo technique guide found online
MicroPort Orthopedics (China) / Suzhou BEST
China
microport.com
Takin Spinal Posterior Fixation System
Takin posterior thoracolumbar fixation named in 2018 Brazil registration news; pedicle-screw design not explicitly stated.
Ask the manufacturerNo technique guide published online
Mikron Medical
Turkey
MSFX Mikron Spinal Fixation SystemAsk the manufacturerNo technique guide published online
Miraclus
India
miraclus.com
MS-I Spinal Fixation; MS-II Dual Thread Spinal Fixation; MIS Pedicle Screw System
Miraclus Orthotech Pvt Ltd confirmed as pedicle screw maker; only product catalogues, no technique guides published.
IFUs →
IFU page lists PDFs by product family; open 'Spinal Implant (Rev-03)'; older IFUs via 'Click For Old IFU' · En
No technique guide published online
MiRus
USA
mirusmed.com
EUROPA Pedicle Screw System; EUROPA Advanced Adult Deformity; EUROPA AIS
Only marketing pages and video; no IFU or technique PDFs.
Ask the manufacturerNo technique guide published online
MJ Surgical
India
mjsurgical.com
Singlelock+ (mono/poly/uniplanar/reduction); Singlelock-Fen; Solitaire dual thread; Delta-II MIS
Pedicle screw range confirmed on thoracolumbar catalogue page; no spine IFU or technique guide published.
IFUs →
e-IFU page grouped by product category; spine section currently links only a general implant/instrument brochu
No technique guide published online
Nanovis
USA
nanovisinc.com
Nano FortiFix (pedicle screw system, per 2020 press)Ask the manufacturerNo technique guide published online
Naton Medical Group
China
natonmedical.com
—
Spine line branded Zhengtian (正天脊柱); pedicle screw system name not confirmed. See also Tianjin Zhengtian row.
Ask the manufacturerNo technique guide published online
Neo Medical
Switzerland
neo-medical.com
Neo Pedicle Screw System (Neo Universal platform)
Single-use instrumentation platform; no technique guide published online.
IFUs →
eIFU search portal; search by product
No technique guide published online
Neoortho
Brazil
neoortho.com.br
—
Site content not readable (script-rendered); no spine documents found.
Ask the manufacturerNo technique guide published online
Neuro France Implants
France
neuro-france.net
—
Ask the manufacturerNo technique guide published online
NeuroStructures
USA
nugensurgical.com
Palladian Pedicle Screw System; PalladianMAX MIS
Rebranded NuGen Surgical; no public technique guide or IFU found.
Ask the manufacturerNo technique guide published online
New Era Orthopaedics
USA
neweraortho.com
NEO Modera Pedicle Screw System; Polyscrew Pedicle Screw System
Systems identified from FDA 510(k)/GUDID records only; no documents online.
Ask the manufacturerNo technique guide published online
Nexus Spine
USA
nexusspine.com
PressON Spinal Fixation System (single-level, multi-level)
PressON is a press-on pedicle screw construct (per patents); no documents published online.
Ask the manufacturerNo technique guide published online
Nexxt Spine
USA
nexxtspine.com
Inertia Pedicle Screw System; Inertia CONNEXX Modular Pedicle Screw System (open, MIS, midline, deformity, navigation)
Midline, deformity and navigation guides also on System Materials page.
IFUs →
System Materials page: find the system, then open 'IFU – Standard' or 'IFU – Navigation' (Showpad share links)
Normmed (Norm Medical Devices)
Turkey
normmed.com.tr
Norm Spinal System
Norm Spinal System had FDA 510(k) K092011; official site not identified.
Ask the manufacturerNo technique guide published online
NovaSpine
France
novaspine.fr
SOCORE
Ask the manufacturerNo technique guide published online
OC Medical Devices (Orthocircle Spine)
USA
OrthoCircle Spine Pedicle Screw System
System known from FDA/GUDID records only; no online IFU or technique.
Ask the manufacturerNo technique guide published online
Oltho
Turkey
oltho.com
Procs thoracolumbar posterior pedicle screw system (mono/polyaxial, spondylolisthesis, cannulated cement screws)
Spinal Implant System catalogue on Google Drive via oltho.com/oltho-files; no IFU/technique.
Ask the manufacturerNo technique guide published online
Orion Biotech
Taiwan
ORION Spinal System
Orion Biotech Inc. (Taipei) received FDA K190600 for ORION Spinal System, Aug 2020.
Ask the manufacturerNo technique guide published online
Ortler Global
Turkey
—Ask the manufacturerNo technique guide published online
Ortopro
Turkey
ortopro.com.tr
Orion Adult Spinal System
Spinal page has short technique description only, no technique PDF.
IFUs →
IFU list by product group; 'Spinal İmplantlar' ORT-IFU-003 Rev 13 (2021) PDF · Turkish
No technique guide published online
Ortosintese
Brazil
ortosintese.com.br
Sistema Evolution Plus Baixo Perfil
General catalogue PDF only; Evolution Plus not explicitly confirmed as pedicle system.
Ask the manufacturerNo technique guide published online
OSD
France
osdevelopment.fr
—Ask the manufacturerNo technique guide published online
OSIMPLANT
Turkey
osimplant.com
OSI; ATHENA; HERA; VESTA (thoracolumbar posterior fixation)
Thoracolumbar product pages list systems but no IFU/technique; pedicle screw not stated explicitly.
Ask the manufacturerNo technique guide published online
Ossea Medical Technology
Brazil
ossea.com.br
Sistema de Parafusos Pediculares TLS
Technique guides reportedly behind EAD platform login; not verified.
IFUs →
IFUs and surgical techniques on Educação Continuada training platform; login required · Portuguese
No technique guide published online
OSTEOMED Implantes
Brazil
osteomedimplantes.com
OSTEOM; DPZ; MINI-OSTEO (MIS); SYSPED (paediatric)
DPZ and Mini-OSTEO have FDA 510(k)s (K150294, K231443).
IFUs →
Single list by product and ANVISA reg. no.; pick revision matching product label date · Portuguese (Brazil)
No technique guide published online
OTIS Biotech
South Korea
ULC Spinal Pedicle Screw System
Otis Biotech Co., Ltd. cleared ULC pedicle screw system 2009; no current web presence located.
Ask the manufacturerNo technique guide published online
Pantheon Spinal
USA
pantheonspinal.com
Pantheon Pedicle Screw and Iliac Bolt Fixation System
Screw system known from 510(k) K241494; not shown on website.
Ask the manufacturerNo technique guide published online
Phamedica
USA
phamedica.com
PHA S1 Spinal System
PHA S1 is a thoracolumbosacral pedicle screw system (510(k) K163011, 2017); no documents online.
Ask the manufacturerNo technique guide published online
Pitkar Orthotools
India
pitkar.com
Unlock; Trigen; C-Gen; K-Gen; Pro MIS Tower
S.H. Pitkar Orthotools; spinal catalogue PDF public but contains no surgical steps.
IFUs →
Operative guidelines/IFU released after enquiry form; password sent by email
No technique guide published online
Precision Spine
USA
precisionspineinc.com
Reform Ti / Reform Ti Modular Pedicle Screw System; Reform Ti MIS CT; Reform MC
PDFs linked as 'Surgical Technique' on product pages; image-heavy so content not text-verified.
IFUs →
Single IFU PDF for the Reform Pedicle Screw System, linked from each product page · English · LBL-IFU-011 Rev
Prism Surgical
Australia
prismsurgical.com.au
Centaur Posterior Pedicle Screw System
Other Prism systems (Aurora, Australis) are anterior lumbar plate/cage, not pedicle screws.
IFUs →
Resources page: IFU PDFs listed per system (Centaur, Aquila, Aurora, reusable instruments) · Australia · Engli
ProSpon
Czech Republic
prospon.cz
—
Lists spinal fixators category but no named system or documents online.
IFUs →
Downloads (Ke stazeni) section - IFU content not verified
No technique guide published online
Reliance Medical Systems
USA
reliance-medical-systems.com
Reliance Spinal Screw System
System name from FDA 510(k)/GUDID records; no documents found online.
Ask the manufacturerNo technique guide published online
Republic Spine
USA
rspine.com
DarkStar Pedicle Screw System (Degenerative, MIS, Deformity)
No IFU or technique documents published.
Ask the manufacturerNo technique guide published online
Rivarp Medical
India
rivarpmedical.com
Kentrospine PSS; Kentrospine D-genIFUs →
eIFU request form
No technique guide published online
Royal Oak Medical Devices
USA
royaloakmed.com
Royal Oak Pedicle Screw System
Pedicle screws known from GUDID; site shows no product documents.
Ask the manufacturerNo technique guide published online
Safe Orthopaedics
France
safeorthopaedics.com
SteriSpine
Known for sterile single-use SteriSpine kits.
Ask the manufacturerNo technique guide published online
SAGICO
USA
sagico.com
SAGICO OSI Spinal System
Technique content behind passcode at sagico.com/surgical-techniques/; OSI system made by Osimplant.
Ask the manufacturerNo technique guide published online
SAI (South America Implants)
Argentina
southamericaimplants.com
—Ask the manufacturerNo technique guide published online
Sanatmetal
Hungary
sanatmetal.com
—IFUs →
Catalogues page; no eIFU portal found
No technique guide published online
Sanyou Medical
China
sanyoumed.com
Zeus Spinal System; Adena-Zina Spinal System
Shanghai Sanyou: Zeus FDA K230961, 2023) and Adena-Zina K231931) pedicle screw systems.
Ask the manufacturerNo technique guide published online
Saspine
South Africa
saspine.co.za
SRC Pedicle Screw System; SRC EVO 6 (MIS); SRC EVO 5 (MIS)
Product page only; contact info@saspine.co.za for documents.
Ask the manufacturerNo technique guide published online
SeohanCare
South Korea
seohancare.com
MEGAFIX Pedicle Screw Spinal System
Seohancare Co., Ltd. (Gimpo); MEGAFIX FDA K191655 (2020). No official site found.
Ask the manufacturerNo technique guide published online
Shandong Kangsheng Medical
China
Spinal Fixation System
Generic-named Spinal Fixation System, FDA K190408 (2020).
Ask the manufacturerNo technique guide published online
Sharma Orthopedic
India
sharmaortho.com
CORE Pedicle Screws System; CORE Minimally Invasive
CORE open and MIS pedicle screw range confirmed; no IFU or technique documents published online.
Ask the manufacturerNo technique guide published online
Showa Ika Kohgyo
Japan
showa-ika.co.jp
—Ask the manufacturerNo technique guide published online
SI-BONE
⚠ Recall 21 Aug: iFuse TORQ Implant System →
USA
si-bone.com
iFuse 3D / TORQ / INTRA (SI joint); iFuse Bedrock Granite; iFuse Granite Onyx (sacropelvic)
Exception row: not a pedicle screw maker; Granite implants connect to pedicle screw rods. No public technique PDFs.
IFUs →
Labeling page: select region, document type and language, then Download; paper IFU via QARA@SI-BONE.com · US,
No technique guide published online
Siora Surgicals
India
siiora.com
AURASPINE Pedicle Screw System
AURASPINE poly/mono/dual-thread pedicle screws; all catalogues only via request form.
Ask the manufacturerNo technique guide published online
SMAIO
France
smaio.com
KHEIRON Spinal Fixation System
Site lists i-KONTROL software suite; pedicle screw implant name not confirmed (site errors).
IFUs →
Downloads page; KHEIRON IFU PDFs hosted under smaio.com/e-ifu/
No technique guide published online
Socko Medical
Taiwan
Socko Vimax Spinal Fixation SystemAsk the manufacturerNo technique guide published online
Solco Biomedical
South Korea
solcospine.com
Chiron Spinal Fixation System; Chiron XT MIS; Vane Pedicle Screw System
Solco Biomedical (US arm solcospine.com); Vane only has brochure (image-only, unverified).
Ask the manufacturer
Spinal Elements
USA
spinalelements.com
Overwatch; Overwatch MIS; Primus MIS; Mercury
IFU portal confirmed. no surgical technique PDFs found publicly.
IFUs →
IFU list by product category (Thoracolumbar Fixation); click system for PDF · English; some Spanish/Portuguese
No technique guide published online
SPINAMER
Turkey
spinamer.com
—
product range not verified.
Ask the manufacturerNo technique guide published online
SpineCraft
USA
spinecraft.com
ASTRA; APEX; AVANT MIS
ASTRA/APEX degenerative, deformity, revision systems; no public IFU or technique.
Ask the manufacturerNo technique guide published online
SpineFrontier
USA
spinefrontier.com
—
Homepage shows LES access technologies; pedicle screw system not confirmed.
Ask the manufacturerNo technique guide published online
SpineSmith
USA
spinesmithusa.com
—
Implants and biologics; pedicle screw system name not verified.
Ask the manufacturerNo technique guide published online
Spineway
France
spineway.com
MONT BLANC; MONT BLANC MIS; KAPHORN; VEOS
All documents in private customer portal.
IFUs →
Customer private area holding all product documents (IFU, technique)
No technique guide published online
Spinofix
USA
—Ask the manufacturerNo technique guide published online
Suzhou Gemmed Medical
China
Gemmed pedicle screw spinal system
Suzhou Gemmed Medical Instrument Co.; FDA K151592 (2015).
Ask the manufacturerNo technique guide published online
Suzhou Sunan Zimmered
China
—Ask the manufacturerNo technique guide published online
Suzhou Youbetter
China
chinayoubetter.com
Reduction Pedicle Screw III (Spina System)
Mono/polyaxial reduction pedicle screws for thoracolumbar fixation; no IFU or technique online.
Ask the manufacturerNo technique guide published online
TDM
South Korea
—Ask the manufacturerNo technique guide published online
Teijin Nakashima Medical
Japan
teijin-nakashima.co.jp
—Ask the manufacturerNo technique guide published online
Teslake
USA
teslake.com
Teslake Spinal System
Rochester NY; IFU covers polyaxial screw/rod Spinal System; MPS product unclear.
IFUs →
Product IFUs page; open 'Pedicle Screw IFU (Rev E)' · English
No technique guide published online
Tianjin Walkman Biomaterial
China
walkman.com.cn
—Ask the manufacturerNo technique guide published online
Tianjin Zhengtian Medical
China
—
Pedicle screw system name not found; Overlaps with Naton row.
Ask the manufacturerNo technique guide published online
TIPMED
Turkey
tipmed.com
—
Spine Systems page names no system; general catalogue/brochure at tipmed.com/documents.
Ask the manufacturerNo technique guide published online
TiTaMED
South Africa
titamed.co.za
TiTaMED Spinal System
Titanium pedicle screw/hook/rod system; no IFU or technique online, contact via website.
Ask the manufacturerNo technique guide published online
TRAUMEC
Brazil
traumec.com.br
Rigid Spine Plus
Rigid Spine Plus spinal fixation system (ANVISA 80455630041); pedicle design not confirmed.
IFUs →
Filter by ANVISA no.; download latest revision issued before product manufacturing date · Portuguese (Brazil)
No technique guide published online
TRIA Spine
Turkey
—Ask the manufacturerNo technique guide published online
TST Rakor
Turkey
tstsan.com
—
Site content not readable; spine products not verified.
Ask the manufacturerNo technique guide published online
TSUNAMI MEDICAL
Italy
tsunamimedical.com
Ventotene (3D-printed screw-rod system, incl. MIS)
Surgical techniques page exists at tsunamimedical.com/surgical-techniques/ behind registration.
Ask the manufacturerNo technique guide published online
U&I Corporation
South Korea
youic.com
OPTIMA
OPTIMA ZS transition screw cleared 2007 via Zimmer Spine (FDA K071880); current range unverified.
Ask the manufacturerNo technique guide published online
Uma Surgicals
India
Uni-Lock pedicle screw rod systemAsk the manufacturerNo technique guide published online
Uteshiya Medicare
India
uteshiyamedicare.com
Break Thru System; Maxima Screw System
Pedicle screw systems confirmed; catalogue page lists untitled Google Drive files, no IFU/technique.
Ask the manufacturerNo technique guide published online
Vast Ortho
India
vastortho.com
Pedicle Screw System (generic; mono/poly/cannulated)
Generic pedicle screw range; general catalogue PDF has spine chapter, no surgical steps verified.
Ask the manufacturerNo technique guide published online
Vincula
Brazil
vincula.com.br
Pedicol Plus; Pedicol Advanced BP; SAFE / SAFE 4.0; MIP (cannulated)
Technique downloads from vincula.com.br/tecnicas-cirurgicas (Coluna section).
IFUs →
List by ANVISA number and description; download PDF · Portuguese (Brazil)
Vy Spine
USA
vyspine.com
VyLink Screw System; VyLink MIS System; VySpan PCT System
'Additional information' for products sits behind distributor login.
Ask the manufacturerNo technique guide published online
Waston Medical
China
wastonchina.com
M10 Series Internal Fixation Spinal System
Changzhou Waston; M10 posterior spinal system named, pedicle-screw design not explicitly stated.
Ask the manufacturerNo technique guide published online
WILTROM
Taiwan
wiltrom.com.tw
Pedicle Screw; Reduction Screw; Percutaneous Screw; CBT Screw (Spinal Fixation System)
Spinal Fixation System page lists screw types without brand names; no documents. MicroPort strategic partner.
Ask the manufacturerNo technique guide published online
Winn Technoserv
India
—Ask the manufacturerNo technique guide published online
Xenco Medical
USA
xencomedical.com
SETx Pedicle Screw System (single-use, sterile)
No IFU or technique found; contact sales@xencomedical.com.
Ask the manufacturerNo technique guide published online
Xenix Medical
USA
xenixmedical.com
RIVA Posterior Fixation System
RIVA assumed pedicle screw-based posterior fixation – unconfirmed (PDF not readable).
IFUs →
Resources section on homepage lists IFU PDFs by product · English · M032 Rev B
No technique guide published online
Xtant Medical
USA
xtantmedical.com
Cortera (open); Fortex; Streamline TL / Streamline MIS; Xpress MIS
No public technique guides; individual IFU PDFs not visible to fetch.
IFUs →
eIFU hub: choose Spinal Implants, then product; printed copy via CS@xtantmedical.com · English (US)
No technique guide published online
Yellowsteps
France
yellowsteps.net
—
Claims pedicle screws but only WeTOP cervical cage documents online; no named pedicle screw system.
IFUs →
Downloads page (only WeTOP cervical cage IFU)
No technique guide published online
YSF Medical
Taiwan
ysfbone.com
—
Listed as OEM; own-brand pedicle screw system not verified.
Ask the manufacturerNo technique guide published online
Z-Medical
Germany
z-medical.de
MIS Z-Pedikelschrauben System; SZ-Pedikelschrauben System; Z-Pedikelschrauben System
Download links redirect to customer login; IFU not published.
Ask the manufacturer
Zavation
USA
zavation.com
Tiger 2 / Tiger 2 X-TAB MIS; Thunderbolt & Thunderbolt EXTAB MIS; Lancer open (ChoiceSpine); Proliant (ChoiceSpine)
No public Zavation Tiger technique guide; ChoiceSpine guides hosted on subsidiary domain.
IFUs →
Zavation IFU page by procedure category (Posterior Fixation); ChoiceSpine IFUs at choicespine-eifu.com (accept
ZheJiang Decans Medical
China
LEO Spinal SystemAsk the manufacturerNo technique guide published online

Growth-friendly, growth-guidance and growth-modulating systems (13)

EARLY-ONSET AND ADOLESCENT SCOLIOSIS

Systems for the skeletally immature spine, grouped by how they work. Regulatory status differs sharply between the US, the UK and the EU — several are approved in the US only under a humanitarian device exemption — and some have a safety-notice history, shown in the highlighted box on each card. Always check the current status and IFU for your country before use.

Growth-friendly (distraction-based)(7)

Rods anchored above and below the curve that are lengthened as the child grows, either in theatre, in clinic with an external magnet, or passively.

MAGEC X

Globus Medical
Made by NuVasive Specialized Orthopedics (NuVasive merged into Globus 2023)

Magnetically controlled growing rod: an internal magnet-driven actuator is lengthened non-invasively in clinic with an external remote controller.

REGULATORY STATUSUS: only the modified MAGEC X is distributed (since July 2021), for children under 10, with a 2-year implantation limit. UK: suspension lifted in 2024 for the modified MAGEC X only; earlier MAGEC versions remain suspended. CE certificate suspended March 2021 and reinstated November 2021 with a shorter permitted implantation time. Current EU availability of MAGEC X to confirm.
SAFETY NOTICES
UK supply of all MAGEC systems suspended, March 2020 (MHRA MDA/2020/011). MHRA alert →
FDA safety communication, July 2021: end-cap separation, seal failure and internal materials not fully tested for biocompatibility. MassDevice report →
UK suspension lifted for the modified MAGEC X only, 2024. DSI/2024/002): rods to be removed after at most 2 years.MHRA notice →
FDA Class 2 recall, April 2025: one lot of MAGEC 2 rods (MC2-5090S) assembled with the wrong rod diameter. FDA recall record →
INSTRUCTIONS FOR USEDevice inserts by country on the Globus eIFU page; NuVasive-legacy products such as MAGEC on the NuVasive eIFU site.
SURGICAL TECHNIQUE GUIDENot published; available from the Globus representative.
Safety noticesTechnique via rep

MARVEL Growing Rods

Globus Medical

Growing rod with a geared expansion mechanism (40 or 60 mm range), lengthened through a small incision with a driver; PEEK bearing surfaces intended to reduce wear.

REGULATORY STATUSFDA 510(k) K213196 (December 2022); US launch July 2023; for patients under 10 with early-onset scoliosis. CE status not found.
INSTRUCTIONS FOR USEDirect link to the current US insert; other regions via the Globus eIFU page.
SURGICAL TECHNIQUE GUIDENot published; available from the Globus representative.
USTechnique via rep

VEPTR / VEPTR II

J&J MedTech (DePuy Synthes)

Vertical expandable prosthetic titanium rib: curved rods anchored to ribs, spine or pelvis that open the chest wall and are expanded surgically as the child grows (thoracic insufficiency syndrome).

REGULATORY STATUSUS: moved from humanitarian approval to ordinary 510(k) clearance (K142587) in November 2014. Current CE-market IFU dated 2024.
INSTRUCTIONS FOR USEChoose European or non-European countries, then VEPTR under Spine.
SURGICAL TECHNIQUE GUIDENot published online; available from the DePuy Synthes representative.
EU and USTechnique via rep

Spring Distraction System (SDS)

Cresco Spine

Compressed springs around a sliding rod give continuous gentle distraction, so the construct lengthens with growth without planned lengthening operations.

REGULATORY STATUSFDA Breakthrough designation; FDA 510(k) K251961 (January 2026). Not yet CE marked (European approval pending, early 2026).
INSTRUCTIONS FOR USEIFU location to confirm; the company website could not be checked.
SURGICAL TECHNIQUE GUIDENot published online; contact Cresco Spine.
US only so farCheck EU status

NEMOST (incl. NEMOST V2)

Euros

One-way self-expanding rod: a connector ratchets along a notched rod segment in 1 mm steps, driven passively by growth and activity.

REGULATORY STATUSCE marked and used in Europe; no FDA status found. Post-market study of NEMOST V2 registered.
SAFETY NOTICES
Field safety notice FSN/FSCA-2021-02, December 2021: more rod sliding than expected with the 5.5 mm Growing Domino. Assemblies must be bilateral; use limited to Risser 0 first-line cases, not previously instrumented or fused spines. Notice (Dutch regulator IGJ) →
INSTRUCTIONS FOR USEIFU location to confirm; contact Euros.
SURGICAL TECHNIQUE GUIDENot published online; contact Euros.
EUSafety notice

Traditional dual growing rods

Several manufacturers

Standard pedicle screw and hook systems configured with tandem or side-by-side connectors and lengthened surgically every few months.

REGULATORY STATUSUS 510(k) growing-rod indication (product code PGM) for: Medtronic CD HORIZON Growth Rod sets; DePuy Synthes ISOLA and EXPEDIUM Growing Spine; Stryker K2M Growing Spine and Xia Growth Rod Conversion Set; Highridge Polaris (ex-Zimmer Biomet); Globus/NuVasive Growth Rod Conversion Set; Orthofix (ex-SeaSpine) Daytona Small Stature; Globus CREO / REVERE. Current availability of each set to confirm.
INSTRUCTIONS FOR USEUse the IFU portal shown for each company in the pedicle screw directory above.
SURGICAL TECHNIQUE GUIDECovered by each system’s own technique guide or a growing-rod supplement; see the company entries above.
See company entries

eLLi Growing Rod System

OrthoPediatrics

Non-invasively lengthened growing rod in development; the drive mechanism has not been published.

REGULATORY STATUSFDA Breakthrough designation (May 2024). Not cleared or marketed as far as we could find — pipeline only.
INSTRUCTIONS FOR USENot marketed.
SURGICAL TECHNIQUE GUIDENot marketed.
In development
Growth guidance(3)

The apex of the curve is corrected and controlled, while the rods slide through anchors at the ends so the spine guides its own growth without planned lengthenings.

SHILLA Growth Guidance System

Medtronic

Apex fused and corrected; rods slide through unlocked screw heads at the ends of the construct.

REGULATORY STATUSCE marked 2012; FDA 510(k) K140750 (July 2014) for skeletally immature patients under 10 with severe progressive early-onset scoliosis.
INSTRUCTIONS FOR USESelect your region, then search for SHILLA.
SURGICAL TECHNIQUE GUIDENot published online; available from the Medtronic representative.
EU and USTechnique via rep

VerteGlide Spinal Growth Guidance System

OrthoPediatrics

Sliding-screw construct that lets the rods glide as the child grows — a modern growth-guidance design.

REGULATORY STATUSFDA 510(k) K241816 (March 2025); US launch September 2025. CE status not found.
INSTRUCTIONS FOR USEeIFU portal; use "Request a document" if the product is not listed.
SURGICAL TECHNIQUE GUIDENot published online; available from OrthoPediatrics.
USTechnique via rep

LSZ-4D

Manufacturer not confirmed

Titanium sliding growth-guidance instrumentation; rods slide in their anchors as the spine grows.

REGULATORY STATUSUsed clinically in Russia and studied in UK research on retrieved devices. Manufacturer and regulatory status not verified.
INSTRUCTIONS FOR USENone found.
SURGICAL TECHNIQUE GUIDENone found.
Growth modulation (fusionless)(3)

Implants that tension the convex side of the curve, or brace it internally, so that growth itself corrects the deformity while preserving motion.

The Tether – Vertebral Body Tethering System

Highridge Medical
Formerly Zimmer Biomet / ZimVie spine

Anterior vertebral body screws on the convex side, joined by a tensioned flexible cord, so asymmetric growth gradually corrects the curve.

REGULATORY STATUSFDA humanitarian device exemption (HDE H190005, August 2019) — the first FDA-approved tethering device; for skeletally immature patients with progressive idiopathic scoliosis (Cobb 30–65°) who have failed or not tolerated bracing. Under an HDE, effectiveness has not been demonstrated. Availability outside the US not stated.
INSTRUCTIONS FOR USEHighridge electronic labelling portal; paper copy from Customer Service.
SURGICAL TECHNIQUE GUIDEAvailable on request from Highridge Customer Service.
US (HDE)Technique on request

REFLECT Scoliosis Correction System

Globus Medical

Vertebral body tethering with screws, staples, a polymer cord and locking caps; the cord is tensioned to correct the curve and modulate growth.

REGULATORY STATUSFDA humanitarian device exemption (HDE H210002, May 2023). Multilingual outside-US IFUs suggest international distribution. CE status to confirm.
INSTRUCTIONS FOR USEChoose Device Inserts, then country and REFLECT (US insert DI196A; outside-US DI196B).
SURGICAL TECHNIQUE GUIDENot published; available from the Globus representative.
US (HDE)Technique via rep

ApiFix MID-C System

OrthoPediatrics
ApiFix Ltd (Israel), acquired 2020

Posterior single rod on the concave side, anchored on two polyaxial pedicle screws, with a one-way self-lengthening ratchet; acts as an internal brace that preserves motion.

REGULATORY STATUSFDA humanitarian device exemption (August 2019) for progressive adolescent idiopathic scoliosis; CE marked. Separate US and outside-US IFUs.
INSTRUCTIONS FOR USEeIFU portal; the product page also lists the US and outside-US IFUs.
SURGICAL TECHNIQUE GUIDEOrthoPediatrics publishes the technique guide openly.
ApiFix surgical technique guide →US edition · English · Rev H (2023)
EU and US

Spine endoscopy systems (21)

SPINE ENDOSCOPY · WORLDWIDE

Endoscope, instrument and platform makers for full-endoscopic, biportal and endoscope-assisted spine surgery, grouped by approach. Few endoscopy companies publish their technique guides — most supply them through representatives and training programmes, which are linked where available.

Full-endoscopic (transforaminal / interlaminar)(8)

Single-portal working-channel endoscopes with their instrument sets, drills and visualisation.

Arthrex

USA

Arthrex Endoscopic Spine (spine endoscope 7.0 mm); WishBone endoscopic instruments; Synergy 4K visualisation / ElectroSurgery; NanoCannula. Procedure pages also cover transforaminal, cervical foraminotomy, medial branch transection.

REGULATORY STATUS
INSTRUCTIONS FOR USEArthrex eDFU site: search by REF, UDI-DI or description, then download in your language.
SURGICAL TECHNIQUE GUIDEArthrex publishes its endoscopic techniques openly.
Global

baholzer Endoskopie-Systeme

Germany

Lumbar disc endoscope side-cutting concept); U-Scope transforaminal/interlaminar, co-created with EOC); Epiduroscopy system. also Mont Blanc MIS fusion and TOPS implants.

REGULATORY STATUS
INSTRUCTIONS FOR USECustomer IFU list (rigid spine instruments, rigid endoscopes under 'Bandscheiben-Endoskopie'); login required to download
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
Customer login

KARL STORZ

Germany

SpineTIP (transforaminal / interlaminar / postero-lateral sets); EASYGO! II tubular endoscopic; DrillCut-X II spine handpiece; VITOM 3D exoscope. Spine brochures in KARL STORZ media library; no step-by-step technique guide located online.

REGULATORY STATUS
INSTRUCTIONS FOR USEKARL STORZ eIFU portal (run via ifucare.io); search by article number; 'Request a document' ticket form if not found
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
Global

MaxMoreSpine (Hoogland Spine Products)

Germany

maxMorespine Endoscope (MAXDISC); maxMorespine instrument system; Mini endoscopic system; Biportal Endoscopic System (BESS). Website maxmorespine.com could not be checked; product info from Medical XPRT listings and FDA records.

REGULATORY STATUSHoogland Spine Products GmbH, Unterföhring (Munich); FDA 510(k) K083552 (endoscope) and K090132 (instruments, June 2009)
INSTRUCTIONS FOR USENo IFU source found.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.

RIWOspine (Richard Wolf)

Germany

VERTEBRIS L; VERTEBRIS C; VERTEBRIS X / X Fusion; VERTEBRIS foraminotomy. Also equipment unit (imaging, fluid, burrs, RF) and evospine fusion implants; RIWOspine Alliance education network.

REGULATORY STATUSRIWOspine GmbH (Knittlingen) is Richard Wolf's spine business; richard-wolf.com spine page redirects to riwospine.com
INSTRUCTIONS FOR USENo IFU on the website; request via the product pages or your representative.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
On request

RZ Medizintechnik

Germany

Discoscopes; Cervical endoscopes. OEM-type endoscope maker named in market reports; website contents unverified.

REGULATORY STATUSRZ Medizintechnik GmbH, Tuttlingen; FDA 510(k) K130778 (spinal endoscopes), Apr 2014
INSTRUCTIONS FOR USELink to follow.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.

Spinendos

Germany

Spine endoscope system whole spine); bipolar RF ablation; image and power systems. Website gives no product names or documents.

REGULATORY STATUSMunich. Reported acquired by Double Medical Technology (China) in 2021. Current ownership to confirm.
INSTRUCTIONS FOR USENo IFU online; site directs to salesperson
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
Via rep
Unilateral biportal endoscopy (UBE / BESS)(6)

Separate viewing and working portals, with dedicated scopes, instrument sets, fluid and RF systems.

Amplify Surgical

USA

dualPortal; dualPortal 2.0; dualPortal Access System; dualX Slim (endoscopic fusion cage). US UBE pioneer; links dualPortal access with dualX expandable cages for endoscopic TLIF.

REGULATORY STATUSFirst dualPortal case announced Nov 2021
INSTRUCTIONS FOR USENo IFU listed on site
SURGICAL TECHNIQUE GUIDEQuick-start guide and a technique paper hosted by Amplify; no formal step-by-step technique guide.
US

Armed Inc.

South Korea

D`UBE UBE/BESS Instrument Set (sheath, 0°/30° endoscopes, retractors, chisels, cage instruments). Regional contacts in Latin America, APAC, USA, CIS.

REGULATORY STATUSHanam-si, Gyeonggi; manufacturing role not explicitly stated
INSTRUCTIONS FOR USENo IFU found
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
On request

Endovision

South Korea

UBE/BESS instrument sets; UBE scope kit (single-use); FREETOME punch. Korean UBE device maker; English site eng.endovision.co.kr. Product names partly unconfirmed.

REGULATORY STATUSFounded 2013, Daegu area (+82-53); manufacturer per tradeKorea
INSTRUCTIONS FOR USENo IFU found; site not reachable for checking
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.

Jiangsu Bonss Medical

China

UBE Surgical Instrument Sets; UBE/Spine RF Plasma Surgical Systems; UBE Surgical Power Systems; 4K UHD Endoscopic System. Supplies UBE RF, power and visualisation systems; may OEM for other brands (unconfirmed).

REGULATORY STATUSTaizhou, Jiangsu (China Medical City)
INSTRUCTIONS FOR USENo downloads/IFU on site; inquiry form
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
On request

Nexon Medical

Switzerland

EnSight UBE biportal endoscopic platform (tower/console, endoscopes, instrument kits, fluid pump, RF). Integrated UBE platform including motorised, ultrasonic, RF and navigation components.

REGULATORY STATUSNexon Medical AG, Oberkirch (Lucerne).
INSTRUCTIONS FOR USENo IFU links on website
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
EU

Solendos (CG MedTech)

Germany / South Korea

UBE/biportal endoscopy system and instrument sets, endoscopic camera platform, RF devices. CG MedTech also markets the Anax MIS system.

REGULATORY STATUSCG MedTech (Korea) acquired 90% of Solendos in December 2025; the technology traces back to MGB Endoscopy. Product brand names not yet published.
INSTRUCTIONS FOR USENo IFU found online; contact the company.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
Full-endoscopic and biportal(2)

Companies offering both approaches.

Elliquence

USA

Endoscopic Spine Systems; Mult-e Portal Endoscopy; Trigger-Flex RF family; Disc-FX System. Workshops in USA, EMEA, South America; Elliquence Japan site exists.

REGULATORY STATUSAcquired by Shanghai Kinetic Medical (China) for about USD 77M, 2018
INSTRUCTIONS FOR USEMDR IFU login page; no per-product IFU links
SURGICAL TECHNIQUE GUIDEOnly an overview brochure is public — not a step-by-step technique.
Login for IFU

Unintech

Germany

EndoSurg Standard / Plus / Max; EndoTLIF; EndoPLIF; EndoSurg Bportal (announced). Full system incl. drill, camera/light, RF generator, irrigation pump; workshops held mainly in China.

REGULATORY STATUSUnintech GmbH, Düsseldorf.
INSTRUCTIONS FOR USEIFU request form (no direct download)
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
On request
Microendoscopic, endoscope-assisted and access systems(5)

Tubular microendoscopy, single-use scopes and endoscope-assisted decompression or fusion systems.

Clarus Medical

USA

Digital ClarusScope (single-use, working channel); Digital NeuroPEN; LASE laser-assisted spinal endoscopy; 3000C flexible scope. Single-use digital spinal endoscopes; website does not yet list the digital scopes.

REGULATORY STATUSMinneapolis; Digital ClarusScope/NeuroPEN FDA 510(k) K240535, Apr 2024
INSTRUCTIONS FOR USENo IFU on website; contact company
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
US

Lesspine Innovations

ELID (Endoscopic Less Invasive Decompression) System. Country and website not identified; ELID details unverified.

REGULATORY STATUSTwo US FDA registrations listed (HaRi database); also Sacrix, Inspan ScrewLES, Invue MAX, FacetFuse
INSTRUCTIONS FOR USENone found.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.

Medtronic

USA / Ireland

METRx System / METRx MED (microendoscopic discectomy, tubular). Only tubular microendoscopic offering; METRx scope attachment sheet hosted by RCH Melbourne not used.

REGULATORY STATUSMETRx still listed (e.g. Medtronic Japan METRx page, current GUDID entries); no full-endoscopic or UBE system found
INSTRUCTIONS FOR USESelect your region, then search for METRx.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
Global

Spineology

USA

OptiLIF Endo (Direct Visualization System, single tubular retractor); OptiMesh expandable implant. Endoscopic lumbar interbody fusion system; website not checked.

REGULATORY STATUSSt. Paul, MN; limited launch of OptiLIF Endo Aug 2022; GUDID lists 'OptiLIF Endo, Direct Visualization System'
INSTRUCTIONS FOR USELink to follow.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
US

SpineView

USA

SpineVu Endoscopic Spine System (SESS); SpineVu Miniscope; enVue cannula; enCise bone cutter. Single-use access/decompression accessories for endoscopic use; current status unknown.

REGULATORY STATUSSpine View, Inc., Fremont CA; FDA K081051 and K121548 (Aug 2012); no current website found – possibly inactive
INSTRUCTIONS FOR USENone found.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the company or its representative.
Status unclear

Artificial disc and nucleus replacement (30)

MOTION PRESERVATION

Cervical and lumbar total disc replacements and nucleus replacement devices. Regulatory status changes often in this field — several discs have changed owner, gained two-level approval or been withdrawn in recent years — so each card states the status as we found it, with the date. Where the manufacturer does not publish the IFU, we link the FDA approval labelling as a fallback, clearly labelled; it may be older than the current IFU.

Cervical disc replacement(15)

Systems currently marketed or recently approved. FDA level approvals (one or two levels) are stated on each card.

activC Cervical Disc Prosthesis

Aesculap (B. Braun)

CoCrMo endplates with spikes and a central keel and a UHMWPE inlay with limited translation.

REGULATORY STATUSCE marked; not FDA approved.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

BAGUERA C Cervical Disc

Spineart

Ti-6Al-4V endplates with titanium plasma spray and DLC-coated articulating surfaces, mobile vitamin-E blended crosslinked PE nucleus; 1 or 2 contiguous levels.

REGULATORY STATUSFDA PMA P250042 approved 10 Aug 2026 (1 or 2 contiguous levels C3-C7), applicant Spineart USA; instruments 510(k) K262639 (14 Aug 2026). CE marked; reimbursed in France (HAS CNEDIMTS opinion June 2023).
INSTRUCTIONS FOR USEFDA approval summary only (not the IFU). Request the IFU from Spineart.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
FDA approvedCE marked

Bryan Cervical Disc

Companion Spine (FDA PMA applicant: Companion Spine France SAS, Merignac)
Formerly Spinal Dynamics -> Medtronic (2002) -> Companion Spine (per FDA PMA record; transfer date not verified)

Titanium shells with porous coating around a polyurethane nucleus, enclosed in a polyurethane sheath; FDA 1 level.

REGULATORY STATUSFDA PMA P060023 (decision 12 May 2009, 1 level). FDA database now lists Companion Spine France SAS as applicant. Current commercial availability not verified.
INSTRUCTIONS FOR USEFDA labelling from the original approval; may be older than the current IFU.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
FDA approved

C-Disc Cervical Prosthesis

Cousin Surgery

Reverse-geometry cervical prosthesis with double centre of rotation and mobile HDPE core; supplied pre-assembled with single-use inserter.

REGULATORY STATUSAcquired by Cousin Surgery (announced Dec 2025); marketed in France, Germany, Spain and UK (CE status implied but not verified); not FDA approved.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
Not FDA approved

CP-ESP Cervical Disc Prosthesis

Spineway Group
Formerly FH Orthopedics -> Spine Innovations (acquired by Spineway 2022)

One-piece viscoelastic implant: polycarbonate-urethane elastomer core bonded between titanium endplates with pegs; no articulating surfaces.

REGULATORY STATUSCE marked; not FDA approved.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

Freedom Cervical Disc

AxioMed

One-piece viscoelastic elastomer core bonded to titanium endplates.

REGULATORY STATUSCE marked 2012; US IDE study (NCT01763619); not FDA approved; current availability not verified.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

Mobi-C Cervical Disc

Highridge Medical
Formerly LDR Medical (France) -> Zimmer Biomet (2016) -> ZimVie (2022) -> Highridge Medical (H.I.G. Capital, 2024)

CoCr endplates with lateral teeth (no keel) and a mobile UHMWPE core; FDA approved for 1 and 2 levels.

REGULATORY STATUSFDA PMA P110002 (1-level) and P110009 (2-level), decision 23 Aug 2013; FDA database now lists Highridge Medical LLC (Westminster, CO) as applicant. CE marked; widely marketed. China market approval January 2009 (LDR).
INSTRUCTIONS FOR USEHighridge eIFU portal (no public search; use “Request a document”). FDA approval labelling as a fallback.
SURGICAL TECHNIQUE GUIDELinks below; videos and brochures are labelled as such.
Mobi-C Cervical Disc Surgical Technique (OUS) →OUS · hosted on former owner’s site
FDA approvedCE marked

MOVE-C Cervical Disc

NGMedical

Additively manufactured (3D-printed) endplates, polyethylene-free design with six-degree-of-freedom motion and progressive axial damping; implanted with a cage-like technique.

REGULATORY STATUSCE marked (end of 2019); not FDA approved. Also launched in Taiwan.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

Prestige LP Cervical Disc

Medtronic

Two-piece titanium-ceramic composite ball-in-trough articulation; dual rails, no keel; FDA approved for 1 or 2 contiguous levels (C3-C7).

REGULATORY STATUSFDA PMA P090029 (decision 24 Jul 2014; two-level indication added by later supplement). Medtronic lists it for 1 or 2 contiguous levels C3-C7. CE marked and marketed outside the US.
INSTRUCTIONS FOR USECurrent versions in the Medtronic Manual Library (select region, search Prestige LP). FDA labelling from the original approval as a fallback.
SURGICAL TECHNIQUE GUIDELinks below; videos and brochures are labelled as such.
FDA approvedCE marked

Prodisc C (incl. Prodisc C Vivo, C SK, C Nova)

Centinel Spine
Formerly Synthes / DePuy Synthes (Prodisc portfolio acquired by Centinel Spine 2017)

CoCrMo endplates with UHMWPE ball-and-socket core (prodisc CORE). Prodisc C: domed endplates with central keel; C Vivo: keel-less with lateral spikes; C SK: flat endplate with low-profile central keel; C Nova: flat endplate with low-profile tri-keels.

REGULATORY STATUSFDA PMA P070001 (Prodisc C, decision 17 Dec 2007, 1-level). C Vivo and C SK approved via supplement 2022 (1-level) and for 2 levels on 14 Oct 2025. C Nova FDA approved for 1 level (limited US release from Oct 2024); 2-level approval for Nova announced Oct 2026, making Nova, Vivo and SK approved for 1-2 levels while original Prodisc C remains 1-level. CE marked; in China registered under Synthes GmbH.
SAFETY NOTICES
China NMPA notice (10 Aug 2016) of a voluntary recall of Prodisc-C Vivo by Synthes GmbH; reason and lots not stated in the third-party record. Notice →
INSTRUCTIONS FOR USEThe FDA site hosts Centinel’s 10/2025 surgical technique for C Vivo and C SK, which includes the labelling. Other IFUs via the Centinel Spine resource request form.
SURGICAL TECHNIQUE GUIDELinks below; videos and brochures are labelled as such.
prodisc C Vivo / C SK surgical technique STG026 Rev 1 (10/2025) →Regulator copy · FDA (accessdata.fda.gov) · US · accuracy not guaranteed
FDA approvedCE marked

ROTAIO Cervical Disc Prosthesis

SIGNUS Medizintechnik

Articulating cervical total disc replacement (design details not verified here).

REGULATORY STATUSCE marked (marketed in Europe); not FDA approved. Current availability not verified.
SAFETY NOTICES
Field safety notice / customer information dated 20 Oct 2016 on post-operative noise (~0.12% of implants; IFU adverse-event list extended); also listed by Swissmedic. Field safety notice (Polish regulator archive) →
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

SECURE-C Cervical Artificial Disc

Globus Medical

CoCrMo endplates with titanium plasma spray and serrated keels, UHMWPE sliding core (selectively constrained). Same IFU also covers OUS variants SECURE-CR (PEEK) and SECURE-C3 (PEEK with PCU core).

REGULATORY STATUSFDA PMA P100003 (2012), 1 level C3-C7. CE marked. SECURE-CR / SECURE-C3 variants are not FDA approved to our knowledge.
INSTRUCTIONS FOR USEDirect link to the current insert (DI126A Rev K, 09/2025); other countries via the Globus eIFU portal.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
FDA approvedCE marked

Simplify Cervical Artificial Disc

Globus Medical
Formerly Simplify Medical -> NuVasive (2021) -> Globus Medical (merger 2023)

PEEK endplates with titanium plasma spray and a semi-constrained mobile zirconia-toughened alumina ceramic core (biconvex dual articulation); designed for low MRI artefact; heights from 4 mm; 1 or 2 levels.

REGULATORY STATUSFDA PMA P200022 (2020, 1 level); 2-level indication via supplement P200022/S003 (2021). Marketed by Globus Medical. CE status not verified.
INSTRUCTIONS FOR USEGlobus eIFU portal (select product). FDA labelling extract as a fallback.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
FDA approved

Synergy Disc

Synergy Spine Solutions Inc. (Louisville, CO)

Three-piece: titanium-alloy endplates with titanium plasma spray and a UHMWPE core with built-in lordosis (0 or 6 deg); heights 5-7 mm; FDA 1 level.

REGULATORY STATUSFDA PMA P250028 approved 26 Feb 2026 (1 level C3-C7); 2-level IDE fully enrolled. Company states 10+ years of commercial use in 10+ countries outside the US (CE details not verified).
INSTRUCTIONS FOR USEFDA approval summary only (not the IFU). Request the IFU from Synergy Spine Solutions.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
FDA approved

Triadyme-C Cervical Disc

Dymicron

Polycrystalline diamond articulating surfaces (tri-lobe design).

REGULATORY STATUSInvestigational: FDA IDE granted; not approved anywhere to our knowledge.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
Investigational
Lumbar disc replacement(3)

Systems currently marketed.

activL Artificial Disc

Aesculap AG (B. Braun); US rights licensed to Highridge Medical (July 2025)

CoCrMo endplates (spike or keel versions) with Plasmapore titanium/calcium-phosphate coating and a mobile UHMWPE inlay (rotation unconstrained, limited translation); lordotic endplate options; single level L4-L5 or L5-S1.

REGULATORY STATUSFDA PMA P120024 (2015); CE marked. Aesculap holds the PMA; Highridge Medical licensed US rights in July 2025 and announced a (limited) US relaunch.
INSTRUCTIONS FOR USEFDA package insert from the 2015 approval as a fallback. Current outside-US IFU from B. Braun / Aesculap; US from Highridge.
FDA approvedCE marked

LP-ESP Lumbar Disc Prosthesis

Spineway Group
Formerly FH Orthopedics -> Spine Innovations (acquired by Spineway 2022)

One-piece viscoelastic elastomer core bonded to titanium endplates with pegs; no articulating surfaces.

REGULATORY STATUSCE marked; not FDA approved.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

Prodisc L

Centinel Spine
Formerly Spine Solutions -> Synthes / DePuy Synthes -> Centinel Spine (2017)

CoCrMo endplates with central keel, lateral spikes and titanium plasma spray, fixed UHMWPE inlay (ball-and-socket, fixed centre of rotation); 6/11 deg lordosis options; the only US lumbar TDR approved for 2 levels.

REGULATORY STATUSFDA PMA P050010 (decision 14 Aug 2006); 2-level US indication via later supplement (Centinel states it is the only US lumbar TDR approved for two levels). CE marked. New instrumentation released 2025.
INSTRUCTIONS FOR USEFDA labelling from the original 2006 approval (outdated). Request the current IFU from Centinel Spine.
SURGICAL TECHNIQUE GUIDELinks below; videos and brochures are labelled as such.
FDA approvedCE marked
Nucleus replacement / annular closure(4)

Nucleus replacement remains largely investigational — each card states whether the device is approved, and where. Barricaid closes the annular defect after discectomy rather than replacing the nucleus, and is included as a related device.

Barricaid Annular Closure Device

Intrinsic Therapeutics

Woven PET fabric occlusion component anchored by a titanium bone anchor into the vertebral body, implanted after lumbar discectomy to close large annular defects.

REGULATORY STATUSFDA PMA P160050 (decision 8 Feb 2019) for patients with large annular defects after limited lumbar discectomy; CE marked. Annular closure device - not a nucleus or disc replacement.
SAFETY NOTICES
BfArM customer information / manufacturer Advisory Notice 08154/19, 19 Jun 2019 (content not reviewed). BfArM notice →
INSTRUCTIONS FOR USEFDA labelling from the original approval as a fallback.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
FDA approvedCE marked

HYDRAFIL System

ReGelTec

Percutaneously injected hydrogel that is heated, injected into the nucleus space and solidifies in situ to augment a degenerated nucleus.

REGULATORY STATUSINVESTIGATIONAL: FDA Breakthrough Device designation (Dec 2020); US IDE pivotal HYDRAFIL-D study (NCT06011551) authorised Sept 2023, first US patient June 2025. Not FDA approved; CE status not verified.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
InvestigationalNot FDA approved

PerQdisc Nucleus Replacement System

Spinal Stabilization Technologies

Minimally invasive lumbar nucleus replacement: a balloon implant placed after nucleotomy and filled in situ to form a custom-fitting implant; single level L1-S1.

REGULATORY STATUSCE marked (announced May 2021); FDA Breakthrough Device designation (2021); NOT FDA approved - investigational in the US. HQ Kilkenny, Ireland; US office Westminster, CO.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
CE markedNot FDA approved

VIA Disc NP (allograft nucleus supplement)

Vivex Biologics

Dehydrated allograft nucleus pulposus tissue, rehydrated and injected percutaneously to supplement a degenerated disc.

REGULATORY STATUSAllograft tissue product; US regulatory pathway not verified here. Under clinical study (ASCEND trial NCT06615505; registries). Not an FDA-approved device.
INSTRUCTIONS FOR USENo IFU found online; request it from the manufacturer.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed (for reference)(8)

Withdrawn or discontinued systems, kept for reference because patients with these implants are still seen in clinic and revision surgery.

Charite Artificial Disc (SB Charite III)

DePuy Synthes (Johnson & Johnson MedTech)
Formerly Link (Waldemar Link) / Link Spine Group -> DePuy Spine

CoCr endplates with teeth and an unconstrained mobile UHMWPE sliding core; single level L4-S1.

REGULATORY STATUSFDA PMA P040006 (2004, first US lumbar TDR). Discontinued (historical; listed for reference only).
INSTRUCTIONS FOR USENo longer marketed; for revision cases, request the IFU from the manufacturer or check the FDA approval record.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

Kineflex|C

SpinalMotion (company no longer active)

CoCr metal-on-metal semi-constrained mobile core cervical disc.

REGULATORY STATUSNot FDA approved (2013 FDA panel cancelled); formerly CE marked; historical.
INSTRUCTIONS FOR USENo longer marketed; for revision cases, request the IFU from the manufacturer or check the FDA approval record.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

M6-C Artificial Cervical Disc

Orthofix
Formerly Spinal Kinetics (acquired by Orthofix 2018)

Artificial viscoelastic polycarbonate-urethane nucleus within a woven UHMWPE fibre annulus and PCU sheath, between titanium endplates with keels; FDA 1 level.

REGULATORY STATUSFDA PMA P170036 (2019), 1 level C3-C7; CE marked. DISCONTINUED: Orthofix announced discontinuation of M6-C and M6-L on 25 Feb 2025 (post-market surveillance obligations continue). Orthofix still hosts IFUs.
INSTRUCTIONS FOR USEOrthofix still hosts the IFUs: US and outside-US versions; Canada and Australia versions on the product page.
SURGICAL TECHNIQUE GUIDELinks below; videos and brochures are labelled as such.
No longer marketed

M6-L Artificial Lumbar Disc

Orthofix
Formerly Spinal Kinetics

Viscoelastic polycarbonate-urethane core with UHMWPE fibre annulus between titanium keeled endplates.

REGULATORY STATUSCE marked only (never FDA approved). DISCONTINUED together with M6-C in early 2025.
INSTRUCTIONS FOR USENo longer marketed; for revision cases, request the IFU from the manufacturer or check the FDA approval record.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

Maverick Total Disc Replacement

Medtronic

Metal-on-metal (CoCr) ball-and-socket lumbar disc with keel.

REGULATORY STATUSNot FDA approved (US IDE completed but no PMA approval); formerly CE marked; no longer marketed - historical, from general knowledge, not re-verified.
INSTRUCTIONS FOR USENo longer marketed; for revision cases, request the IFU from the manufacturer or check the FDA approval record.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

PCM Cervical Disc

NuVasive (now part of Globus Medical)
Formerly Cervitech -> NuVasive

CoCrMo endplates with UHMWPE bearing, low-radius-of-curvature design, serrated surfaces; FDA 1 level.

REGULATORY STATUSFDA PMA P100012 (decision 26 Oct 2012); PMA WITHDRAWN 22 Apr 2020 per FDA database. Historical.
INSTRUCTIONS FOR USEFDA PMA labeling (historical).
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

PDN Prosthetic Disc Nucleus / HydraFlex

Raymedica (company no longer active)

Hydrogel pellets in polyethylene jacket replacing the nucleus.

REGULATORY STATUSHistorical: CE marked and approved in China; never FDA approved; no longer marketed.
INSTRUCTIONS FOR USENo longer marketed; for revision cases, request the IFU from the manufacturer or check the FDA approval record.
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

Prestige ST / Prestige Cervical Disc

Medtronic

Stainless-steel ball-in-trough metal-on-metal articulation fixed with anterior screws; FDA 1 level.

REGULATORY STATUSFDA PMA P060018 (decision 16 Jul 2007); PMA WITHDRAWN 25 Mar 2021 per FDA database. Historical.
INSTRUCTIONS FOR USEFDA PMA labeling (historical).
SURGICAL TECHNIQUE GUIDENo technique guide found online; available from the manufacturer or its representative.
No longer marketed

Spine retractor systems (37)

ACCESS AND RETRACTION

Retractor systems grouped by approach. Retractors are reusable or single-use instruments rather than implants, so their instructions for use usually cover assembly, cleaning and reprocessing; few manufacturers publish technique or assembly guides online.

Anterior cervical(7)

Self-retaining and table-mounted retractors for ACDF and corpectomy.

CASPAR Cervical Retractor System (CCR, titanium)

Aesculap (B. Braun)

Self-retaining cervical retractor with interchangeable smooth/toothed blades (radiolucent option) plus Caspar distraction pins; reusable

REGULATORY STATUSLong-established; current catalogue
INSTRUCTIONS FOR USEB. Braun eIFU via rep/local B. Braun site (portal not confirmed)
SURGICAL TECHNIQUE GUIDEPublished material below; catalogues and brochures are labelled as such and are not step-by-step guides unless stated.

MaXcess-C Access System

Globus Medical
Formerly NuVasive

Anterior cervical access retractor derived from the MaXcess platform; reusable

REGULATORY STATUSCurrent product page on Globus site
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Black Belt Cervical Retractor System

Koros USA

Self-retaining cervical retractor frames (right/left/offset) with pronged, blunt, spike and T-shaped blades 34-85 mm, all-titanium option and microdiscectomy attachment; reusable, steam sterilised

REGULATORY STATUSGUDID listings current (incl. 'Black Belt Legend' set)
INSTRUCTIONS FOR USEAsk the manufacturer
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.

Cervicalino (MIS cervical)

Medicon eG

Compact retractor system for minimally invasive cervical approaches; reusable

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEMedicon general IFU 'Retention systems: clips, retractors' (IFU-0009, 2026) covering reusable self-retaining retractors and reprocessing; does not name the specific system - confirm with Medicon
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.

Spread-iT 2 (cervical)

Medicon eG

Self-retaining cervical spine retractor system with interchangeable blades; reusable

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEMedicon general IFU 'Retention systems: clips, retractors' (IFU-0009, 2026) covering reusable self-retaining retractors and reprocessing; does not name the specific system - confirm with Medicon
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.

Trimline anterior cervical retractor

Medtronic
Formerly Sofamor Danek

Self-retaining low-profile frame with interchangeable toothed/blunt blades for ACDF; reusable

REGULATORY STATUSOlder system; current availability unclear - seen mainly on secondary/used markets
INSTRUCTIONS FOR USEMedtronic eManuals portal: search by product name or REF number, then select country/language
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Thompson cervical retractor system (e.g. model SL82043)

Thompson Surgical Instruments

Table-mounted cervical retractor with hands-free blade holding, independent medial/lateral retraction, optional integrated light; reusable; Thompson also offers MIS (Thompson MIS division) and posterior/ALIF frame systems; reusable 'Mini Retractor Lite LED' light for anterior cervical use

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USENot published online; request from Thompson
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Anterior lumbar / oblique(8)

Ring, frame and blade systems for ALIF and oblique (pre-psoas) access.

SynFrame

DePuy Synthes (Johnson & Johnson MedTech)
Formerly Synthes

Table-mounted ring frame with adjustable arms and interchangeable blades, radiolucent options and light sources; used for anterior/lateral thoracolumbar and other approaches; reusable

REGULATORY STATUSLong-established; GUDID listings current
INSTRUCTIONS FOR USEComponent IFU (SE_030558 AB, 08/2017) for SynFrame Basic System holding ring, guiding tube and angled rod; other components via the DePuy Synthes eIFU portal (ifu.depuysynthes.com)
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

ALLEGIANCE Retractor System

Globus Medical

Table-mounted anterior retractor system for anterior lumbar approaches; reusable

REGULATORY STATUSCurrent product page
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

MARS Lateral ALIF Retractor

Globus Medical

Retractor for lateral-position ALIF (L5-S1 in lateral decubitus), table-mounted blades; part of MARS family

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Supine ALIF Retractor System

Globus Medical
Formerly NuVasive (likely legacy product; not confirmed)

Retractor system for supine ALIF; reusable

REGULATORY STATUSCurrent product page
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Omni-Tract Spine-Tract System

Integra LifeSciences
Formerly Omni-Tract Surgical (acquired by Integra)

Table-mounted self-retaining ring/post retractor with spine-specific blades for anterior lumbar and other approaches; reusable

REGULATORY STATUSCurrent Integra brochure
INSTRUCTIONS FOR USEIntegra IFU via rep / Integra website (portal not confirmed)
SURGICAL TECHNIQUE GUIDEPublished material below; catalogues and brochures are labelled as such and are not step-by-step guides unless stated.

OLIF25 / OLIF51 retractor sets

Medtronic

Oblique pre-psoas (OLIF25) and L5-S1 (OLIF51) access; OLIF25 retractor offers flat and round blades, flat blade allows single-step dilation, flex arm with T-handle fine adjustment

REGULATORY STATUSMarketed regionally (Medtronic ME/EU pages)
INSTRUCTIONS FOR USEMedtronic eManuals portal: search by product name or REF number, then select country/language
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Phantom AL retractor (and Phantom ML3)

TeDan Surgical Innovations

Phantom AL: retractor for MIS ALIF; Phantom ML3: MIS posterior lumbar access; reusable

REGULATORY STATUSLaunch 2015 (AL); ML3 later
INSTRUCTIONS FOR USEIFU via TeDan
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

LITe Anterior Retractor

VB Spine (US); Stryker elsewhere pending transfer
Formerly Stryker Spine

Retractor for anterior lumbar (ALIF) access; reusable

REGULATORY STATUSStryker US product page states 'Now sold by VB Spine' (US spinal implants business sold 2025; international transfer planned)
INSTRUCTIONS FOR USENo public IFU link on product page; request from VB Spine / Stryker rep
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep
Lateral access(4)

Transpsoas lateral retractors, usually integrated with neuromonitoring and a lateral interbody system.

Squadron Lateral Retractor (PTP / LTP)

Alphatec Spine (ATEC)

Lateral retractor launched 2017 with Battalion lateral system; used for ATEC lateral and prone transpsoas (PTP) approaches with SafeOp neuromonitoring

REGULATORY STATUSCurrent within ATEC lateral platform
INSTRUCTIONS FOR USEATEC IFU page: filter Product category 'Retractors & Manual Instrument Systems' or search 'Squadron'; country filter AU/NZ/US
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

MaXcess 4 Lateral Access System

Globus Medical
Formerly NuVasive (merged into Globus 2023)

Three-blade split-blade lateral transpsoas retractor, surgeon-controlled independent blade movement, integrated with NVM5/Pulse neuromonitoring (XLIF); table-mounted; reusable with disposable components

REGULATORY STATUSCurrent; NuVasive IFUs via legacy link on Globus eIFU page
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique guide is published by Globus; ask your representative or use the contact page.
Technique via rep

Timberline Lateral Fusion System (retractor)

Highridge Medical
Formerly Zimmer Biomet Spine -> ZimVie -> Highridge

Lateral transpsoas retractor integrated with Timberline lateral interbody system; neuromonitoring-compatible

REGULATORY STATUSCurrent; documents still hosted on legacy zimvie.com
INSTRUCTIONS FOR USEHighridge eIFU portal: search by system name
SURGICAL TECHNIQUE GUIDEPublished material below; catalogues and brochures are labelled as such and are not step-by-step guides unless stated.

Lattus Lateral Access System

Orthofix Medical
Formerly SeaSpine (merged 2023)

Three-blade lateral retractor, top-loading blades expanding independently cranial/caudal/posterior, pivot and sweep, two-point table-arm attachment

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USELinked from Orthofix Lattus page as 'Lattus eIFU' (legacy SeaSpine eIFU portal)
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep
MIS posterior (tubular & expandable)(12)

Tubular, expandable and pedicle-based retractors for minimally invasive decompression and TLIF.

Spyder MIS Retractor System

Aesculap (B. Braun)

Frame retractor adjustable cranio-caudally and medio-laterally, removable top-loading radiolucent titanium-alloy blades that tilt, optional integrated light, mounts on Aesculap holding arm; designed with S4 pedicle screw system (~30 mm incision)

REGULATORY STATUSLaunched 2010 (US); current availability not confirmed
INSTRUCTIONS FOR USEIFU via B. Braun/Aesculap rep
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Insight Retractor and Tube Systems

DePuy Synthes (Johnson & Johnson MedTech)
Formerly Synthes

Tubular and blade-type MIS retractors with table-mounted arm; AO-approved solution (2010)

REGULATORY STATUSOlder system; current availability not confirmed
INSTRUCTIONS FOR USEDePuy Synthes eIFU portal: search by product name or IFU number; select region
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

PIPELINE / PIPELINE II Access System

DePuy Synthes (Johnson & Johnson MedTech)
Formerly DePuy Spine

Expandable MIS access retractor for posterior lumbar procedures; reusable

REGULATORY STATUSFDA 510(k) K062814 (Pipeline II); GUDID entries listed; current marketing status not confirmed
INSTRUCTIONS FOR USEDePuy Synthes eIFU portal: search by product name or IFU number; select region
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

MARS 3V Retractor

Globus Medical

Lightweight radiolucent aluminium minimal-access retractor; independent blades angle up to 20 degrees; light can be routed through the blade walls; table-mounted; reusable

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

MARS TLIF Retractor

Globus Medical

TLIF-specific retractor in the MARS family; reusable

REGULATORY STATUSCurrent product page
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

MAS TLIF 2

Globus Medical
Formerly NuVasive

Pedicle-based less-invasive access system anchored to modular shanks, quick-connect blades, adjustable retraction and independent blade splay; reusable

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

CENTRIC-T / CENTRIC-R retractors

Life Spine

CENTRIC-T: pedicle-based MIS retractor (first case 2018); CENTRIC-R: expandable MIS retractor

REGULATORY STATUSCurrent status not confirmed
INSTRUCTIONS FOR USENo public IFU found
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

MAST QUADRANT Retractor System

Medtronic
Formerly Sofamor Danek

Expandable split-blade tubular retractor on table-mounted arm, dilator insertion, blade extensions; part of MAST minimally invasive platform

REGULATORY STATUSCleared FDA K043602 (2004); still listed on GUDID
INSTRUCTIONS FOR USEMedtronic eManuals portal: search by product name or REF number, then select country/language
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

METRx System (tubular retractors)

Medtronic
Formerly Sofamor Danek

Sequential dilators with fixed-diameter disposable or reusable tubes on a table-mounted flexible arm; used with microscope or endoscope (METRx-MED)

REGULATORY STATUSLong-established; still listed (GUDID entries current)
INSTRUCTIONS FOR USEMedtronic eManuals portal: search by product name or REF number, then select country/language
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Fathom Pedicle Based Retractor

Orthofix Medical
Formerly SeaSpine

Pedicle-screw-based MIS retractor for posterior TLIF/decompression; launched 2023

REGULATORY STATUSCurrent
SAFETY NOTICES
FDA Class 2 recall, initiated 17 May 2024 (posted 28 Jun 2024): Fathom C/C blade 50-80 mm (MR2102050) manufactured incorrectly, risk of fracture. FDA recall record →
INSTRUCTIONS FOR USELegacy SeaSpine eIFU portal (used for Orthofix/SeaSpine spine products; Fathom entry not individually confirmed)
SURGICAL TECHNIQUE GUIDEPublished material below; catalogues and brochures are labelled as such and are not step-by-step guides unless stated.

LITe Pedicle Based Retractor (PBR) System

VB Spine (US); Stryker elsewhere pending transfer
Formerly Stryker Spine

MIS retractor that docks onto ES2 pedicle screws for less invasive access under direct vision; reusable

REGULATORY STATUSStryker US product page states 'Now sold by VB Spine' (US spinal implants business sold 2025; international transfer planned)
INSTRUCTIONS FOR USENo public IFU link on product page; request from VB Spine / Stryker rep
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Luxor Retractor

VB Spine (US); Stryker elsewhere pending transfer
Formerly Stryker Spine

Expandable MIS retractor with integrated illumination for posterior lumbar access; reusable frame

REGULATORY STATUSStryker US product page states 'Now sold by VB Spine' (US spinal implants business sold 2025; international transfer planned)
INSTRUCTIONS FOR USENo public IFU link on product page; request from VB Spine / Stryker rep
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep
Open posterior(5)

Branded self-retaining systems for open and mini-open posterior surgery.

CASPAR Lumbar Retractor System (CLR)

Aesculap (B. Braun)

Self-retaining lumbar retractor for microsurgical (micro-)discectomy with hook and blade options; reusable

REGULATORY STATUSCurrent catalogue
INSTRUCTIONS FOR USEIFU via rep
SURGICAL TECHNIQUE GUIDEPublished material below; catalogues and brochures are labelled as such and are not step-by-step guides unless stated.

MARS Midline Retractor

Globus Medical

Midline posterior retractor in the MARS family for open/mini-open approaches; reusable

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEGlobus eIFU form: choose 'Device Inserts', country and product; separate link on the same page for legacy NuVasive product IFUs
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep

Mentor Cervical/Lumbar and Quick Change Spinal Retractor sets

Koros USA

Reusable self-retaining spinal retractor sets for cervical and lumbar (micro)surgery with interchangeable blades

REGULATORY STATUSGUDID listings current
INSTRUCTIONS FOR USEAsk the manufacturer
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.

Spread-iT (thoracic and lumbar)

Medicon eG

Self-retaining retractor system for thoracic and lumbar spine with blade sets; reusable

REGULATORY STATUSCurrent
INSTRUCTIONS FOR USEMedicon general IFU 'Retention systems: clips, retractors' (IFU-0009, 2026) covering reusable self-retaining retractors and reprocessing; does not name the specific system - confirm with Medicon
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.

LITe Midline Retractor System

VB Spine (US); Stryker elsewhere pending transfer
Formerly Stryker Spine

Self-retaining midline posterior retractor for open/mini-open decompression and fusion; interchangeable blades; reusable

REGULATORY STATUSStryker US product page states 'Now sold by VB Spine' (US spinal implants business sold 2025; international transfer planned)
INSTRUCTIONS FOR USENo public IFU link on product page; request from VB Spine / Stryker rep
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep
Illuminated / single-use(1)

Single-use or illuminated retractors marketed for spine.

Invuity illuminated retractors for spine (e.g. Eigr, Breiten)

Stryker
Formerly Invuity (acquired by Stryker 2018)

Single-use waveguide-illuminated retractor blades/systems giving cool, shadow-free light in the wound; spine-specific systems were launched by Invuity

REGULATORY STATUSStatus of individual spine models under Stryker not confirmed
INSTRUCTIONS FOR USEIFU via Stryker rep
SURGICAL TECHNIQUE GUIDENo technique or assembly guide found online; available from the manufacturer or its representative.
Technique via rep
FOUND A BROKEN LINK?

Manufacturer portals change often. If a link no longer works, a newer technique guide has been published, or a system you use is missing, tell us at spinalfrontiers@nspine.com and we will check it before the next issue.

How we compile this page

We link the instructions for use and technique guides that each manufacturer or a regulator publishes, and the manufacturer’s request or contact page where neither does. Systems are grouped by device type and listed alphabetically; the directory is a selection and not exhaustive, and inclusion is not an endorsement. Always use the IFU supplied with the set or the current eIFU for your country. Corrections: spinalfrontiers@nspine.com.

For recap and orientation only. Always follow the IFU supplied with the set, or the current eIFU for your country and lot. Indications, available components and techniques differ between regions and change over time. This directory is a selection, listed alphabetically, and is not exhaustive; inclusion is not an endorsement and no ranking is implied. Technique guides are linked only where the manufacturer or a regulator publishes them; otherwise we link the manufacturer’s request or contact page. Spinal Frontiers is independent of the manufacturers listed and receives no payment for inclusion. All IFUs and technique guides belong to their manufacturers — we say where to find them and link to the original.

Last link check: 25 October 2026 · © 2026 NSpine · Spinal Frontiers

Listings are a selection made at NSpine's editorial discretion and are not exhaustive. Inclusion is not an endorsement, and omission implies nothing.

Spinal Frontiers is published by NSpine Limited, registered in England and Wales (company no. 08362634), 14 Park Row, Nottingham NG1 6GR, United Kingdom. Every item is summarised in our own words and links to its original source. Listings are a selection made at NSpine's editorial discretion and are not exhaustive; inclusion is not an endorsement, and omission implies nothing. Sponsors and advertisers have no influence on what we cover. Nothing here is medical, legal or financial advice. Spotted an error or a broken link? Email spinalfrontiers@nspine.com, or use the feedback page.

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