Spinal FrontiersPowered by NSpineWeekly alert sign-up
← Back

Spinal Frontiers · Medtech & Innovation · Spine Theatre Builder

Spine Theatre Builder

Equipping a spine operating theatre, area by area: who makes what, listed alphabetically.

35 makers in 4 areas · 16 advanced systems · 9 integration makers · 20-point planning checklist · emerging technology

Planning or re-equipping a spine theatre? A neutral A–Z of the makers in each equipment area, with a link to each product page. No rankings, no prices and no recommendations: compare for yourself.

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

Operating tables & positioning

USA

Bone Foam

Foam-based patient positioning systems for orthopaedic and spine procedures, including a Universal Prone Positioning System and the Nextend anterior cervical positioning system

Product page →Source checked

Sweden

Getinge (Maquet)

Maquet Magnus and Otesus OR table systems; Maquet mobile tables (Corin, Meera, Lyra, Betaclassic, Yuno II); neurosurgical and positioning accessories

Product page →Source checked

Germany

medifa

medifa 8000 carbon imaging operating table with 360-degree radiolucent surface; medifa 5000-7000 mobile operating tables

Product page →Source checked

USA

Mizuho OSI

ProAxis spinal surgery table; Trios, Modular Table System and Allegro imaging tables; Wilson Plus radiolucent lumbar frame; ProneView helmet, Levo head positioner and GentleTouch prone pillows

Product page →Source checked

Switzerland

Schaerer Medical

Schaerer 7300 spine table (converts to an open-frame four-post prone table); ARCUS mobile tables; Carbon Spine Frame (CSF) accessory

Product page →Source checked

USA

Skytron

Surgical tables including the 3008 Clarity imaging table and top-slide/rotation tables (UltraSlide, Elite, Hercules)

Product page →Source checked

Ireland

STERIS

CMAX image-guided surgical table with 360-degree radiolucent carbon-fibre top; 4095 and 7080 general tables with long imaging windows

Product page →Source checked

Intraoperative imaging

Germany

Brainlab

Loop-X mobile robotic imaging device (2D fluoroscopy and 3D cone-beam CT) with spine incision planning and longitudinal scans for multi-level constructs

Regulatory
Official page states the onboard tracking camera is not yet commercially available in several countries.

Product page →Source checked

Japan

Fujifilm

Persona C mobile fluoroscopy C-arm for surgical imaging (the product page does not name spine specifically)

Product page →Source checked

USA

GE HealthCare

OEC 3D mobile 2D/3D imaging C-arm with Spine Suite planning tools (screw detection, vertebra labelling)

Product page →Source checked

USA

Globus Medical

Excelsius3D mobile imaging (3D cone-beam CT, 2D fluoroscopy and radiography) with automatic registration to ExcelsiusGPS

Regulatory
Official page states the system is not intended for diagnostic use.

Product page →Source checked

Ireland

Medtronic

O-arm O2 surgical imaging system (2D and 3D, 360-degree gantry) with O-arm 4.3 software (3D Long Scan, Spine Smart Dose); pairs with StealthStation navigation

Regulatory
Official page gives an indication for adult and paediatric patients of 27 kg or more and notes intended use may vary with regional approvals.

Product page →Source checked

Netherlands

Philips

Zenition mobile C-arm family (Zenition 70 with spine settings and navigation link; Zenition 50); Azurion hybrid OR systems with SmartCT cone-beam CT for spine

Regulatory
Philips spine hybrid OR page states product availability is subject to country regulatory clearance.

Product page →Source checked

Germany

Siemens Healthineers

Cios Spin mobile 2D/3D C-arm (Screw Scout, NaviLink 3D interface to navigation systems); ARTIS pheno robotic C-arm for hybrid OR spine work

Regulatory
Official page states the products are not available in all countries.

Product page →Source checked

USA

Stryker

Airo TruCT mobile intraoperative fan-beam CT (32-row detector, DICOM export to navigation)

Product page →Source checked

Germany

Ziehm Imaging

Ziehm Vision RFD 3D mobile C-arm with 3D imaging and screw visualisation for spinal surgery

Regulatory
Official page states some products or features may not be available in the United States owing to lacking FDA clearance.

Product page →Source checked

Navigation & robotics

USA

Augmedics

xvision Spine System augmented-reality headset navigation for open and percutaneous spine procedures

Regulatory
Official page states FDA authorisation for open or percutaneous spine procedures from C3 to the pelvis.

Product page →Source checked

Germany

Brainlab

Cirq robotic arm for trajectory alignment; Spine & Trauma Navigation; integrates with Loop-X imaging

Product page →Source checked

France

eCential Robotics

All-in-one platform combining 2D/3D imaging, real-time navigation and robotics for bone surgery; co-developer of the DePuy Synthes VELYS Spine system

Product page →Source checked

USA

Globus Medical

ExcelsiusGPS robotic navigation (screw and interbody placement; TLIF, LLIF and SI workflows); ExcelsiusHub navigation; ExcelsiusXR extended-reality headset; Excelsius3D imaging

Product page →Source checked

USA

Johnson & Johnson MedTech (DePuy Synthes)

VELYS Active Robotic-Assisted System (VELYS SPINE): standalone navigation plus active robotics for cervical, thoracolumbar and sacroiliac fusion with DePuy Synthes instruments

Regulatory
Official launch release (Aug 2024) states US FDA 510(k) clearance.

Product page →Source checked

Ireland

Medtronic

StealthStation S8 spine navigation (with O-arm); Mazor X Stealth Edition robotic guidance; Stealth AXiS surgical system with Spine application and Autopilot robotic arm

Regulatory
FDA 510(k) database lists Stealth AXiS with Spine application (K253381) cleared 12 February 2026.

Product page →Source checked

USA

Orthofix

7D FLASH Navigation System: machine-vision camera in the overhead light, for spine and cranial navigation

Product page →Source checked

USA

Stryker

Q Guidance System with Spine Guidance Software (hybrid optical tracking; automatic registration with Airo TruCT)

Regulatory
Official page states the Spine Guidance Software received FDA clearance for patients aged 13 and older.

Product page →Source checked

USA

Zimmer Biomet

ROSA ONE Spine robotic and navigation system for thoracolumbar surgery, with dynamic patient tracking

Regulatory
Company release (25 March 2019) states FDA 510(k) clearance.

Product page →Source checked

Surgical microscopes & exoscopes

Germany

B. Braun (Aesculap)

Aesculap Aeos robotic digital surgical microscope platform, used in neurosurgery and spine surgery

Regulatory
Official page states not all products are registered and approved for sale in all countries or regions.

Product page →Source checked

Germany

KARL STORZ

VITOM exoscope family, including the VITOM eagle exoscope (named for ENT, neurosurgery and spinal surgery) and VITOM 3D

Regulatory
Official page states it may describe products not yet approved in all countries.

Product page →Source checked

Germany

Leica Microsystems

ARveo 8 digital visualisation microscope (oculars, 4K 3D heads-up or MyVeo headset; GLOW800 fluorescence); PROvido and M530 OHX surgical microscopes; spine surgery listed as an application

Regulatory
Official page states not all products are approved or offered in every market.

Product page →Source checked

Japan

Olympus

ORBEYE 4K 3D exoscope (zoom x1-x26, heads-up viewing), presented for spine surgery among other specialties

Product page →Source checked

Canada

Synaptive Medical

Modus X robotic exoscope with 4K 3D optics and fluorescence visualisation

Regulatory
Official site asks users to contact the company for regulatory clearance status in their jurisdiction.

Product page →Source checked

Germany

ZEISS Medical Technology

KINEVO 900 S robotic visualisation system / surgical microscope, presented for brain and spine surgery

Regulatory
Official page states the products shown may not be available in the US and approved labelling varies by country.

Product page →Source checked

Planning, ventilation, radiation and ergonomics standards

Hybrid suites, intraoperative CT/MRI and spine robots: space needs

Figures only where the maker publishes them; "not published" means ask the maker for its site-planning guide.

Maker and systemTypeRoom sizeWeight or floor loadAlso needs
GE HealthCare
Discovery IGS 7 OR (hybrid OR angiography on a mobile, laser-guided gantry)
hybrid suiteMinimum room size stated as 35 m² (377 ft²)not publishedUntethered gantry with no floor rails or ceiling suspension, so it can be parked aside when not in use; integrated with Maquet Magnus radiolucent tabletopsSpec ↗
Philips
Azurion 7 hybrid OR (example room layouts)
hybrid suiteExample layout (not a stated minimum): operating room 68.3 m², control room 15.2 m², technical room 10.1 m²not publishedCeiling structural support level at 2,700 mm or 2,900 mm above finished floor (+10/−0 mm) in the example drawing; Philips states the drawing is for inspiration only and site-specific design must be agreed with PhilipsSpec ↗
Siemens Healthineers
ARTIS pheno (robotic C-arm for hybrid OR)
hybrid suiteRecommended room ≥ 68 m² (732 ft²); minimum technical room size 35 m² (377 ft²)not publishedFloor-mounted robotic C-arm, leaving the ceiling free; 130 cm source-to-image distance and 95.5 cm usable clearance; flexible isocentre working height 104–150 cm needs the optional syngo DynaCT Large VolumeSpec ↗
Siemens Healthineers
Nexaris Angio-CT and Nexaris Angio-MR-CT therapy suites
hybrid suitenot published (Siemens offers project-specific layout planning)not publishedAngio-MR-CT combines ARTIS angiography, MAGNETOM MRI and a SOMATOM CT on rails in one environment, with the PILOT patient-transfer system (developed with Getinge); in the Angio-CT suite the CT can slide between rooms and be parked when not in useSpec ↗
Stryker
Airo TruCT (mobile intraoperative CT, originally Mobius Imaging)
intraoperative CTnot published816 kg (1,800 lb) plus optional column 159 kg (350 lb)Battery-driven mobility (about 1 mph forward); recharges from a standard outlet; 32-row CT with 1 m scan range; footprint and bore not stated on the official pageSpec ↗
IMRIS (IMRIS Imaging, Inc.)
InVision 3T Operating Suite (moving intraoperative MRI)
intraoperative MRInot published (offered as two-room or three-room suites: diagnostic room plus one or two operating rooms, each with a control room)Magnet weight 5,500 kg with cryogens (3 T, 70 cm bore, magnet length 1.72 m)Magnet travels on a ceiling-mounted rail system between the diagnostic room and adjacent operating rooms; actively shielded magnet with external interference shielding; air curtain around the patient on the OR tableSpec ↗
Brainlab
Loop-X mobile robotic imaging (2D/3D cone-beam CT)
mobile 3D imagingnot publishednot publishedFootprint stated as 1.5 m²; gantry opening 121 cm; 43 × 43 cm flat-panel detectorSpec ↗
Globus Medical
Excelsius3D intraoperative imaging
mobile 3D imagingnot publishednot published (spec sheet available on request only)not publishedSpec ↗
Medtronic
O-arm O2 surgical imaging system
mobile 3D imagingnot publishednot published on the product page (Medtronic refers to a separate Technical Specification Guide covering environmental and power specifications)40 cm field of view and 3D long scan up to 43.8 cmSpec ↗
ATEC Spine (Alphatec)
Valence robotic guidance and navigation
spine robotnot publishednot publishednot publishedSpec ↗
Brainlab
Cirq robotic arm
spine robotnot publishednot published (described as lightweight)Mounts on the operating-table side rail with a stabilising brace, so it takes no floor space; 7 degrees of freedom; no separate control unitSpec ↗
Globus Medical
ExcelsiusGPS robotic navigation and ExcelsiusHub navigation
spine robotnot publishednot published (spec sheet on request)ExcelsiusGPS has a mobile base station and separate camera stand; ExcelsiusHub is a single-footprint cart with an integrated 6-foot camera arm and two 27-inch touchscreensSpec ↗
Johnson & Johnson MedTech (DePuy Synthes)
VELYS Active Robotic-Assisted System (VELYS SPINE), developed with eCential Robotics
spine robotnot publishednot publishednot published; launched in the US in August 2024 with commercial availability expected in the first half of 2025Spec ↗
Medtronic
Mazor X Stealth Edition robotic guidance
spine robotnot publishednot publishednot published on the official page checkedSpec ↗
Medtronic
Stealth AXiS surgical system (integrated planning, navigation and robotics)
spine robotnot publishednot publishednot published; FDA-cleared for spine on 13 February 2026, with a modular design for hospitals and ambulatory surgery centres and LiveAlign real-time tracking of anatomical motionSpec ↗
Zimmer Biomet
ROSA ONE Spine
spine robotnot publishednot publishednot published; FDA-cleared in 2019 for thoracolumbar procedures, with dynamic tracking so no attachment to the patient or table is neededSpec ↗

Theatre integration and video routing, A–Z

Belgium

Barco

Nexxis (AV-over-IP)

Network platform that carries uncompressed 4K surgical video and audio between devices and displays in the theatre, between theatres and out to auditoriums.

Product page →Source checked

Germany

Brainlab

Buzz digital O.R. (Buzz Navigation, Buzz Compact, Buzz In-Wall)

Network-based hub for routing, displaying, streaming and recording images, video and planning software, with a ceiling-mounted version that combines it with navigation.

Product page →Source checked

Germany

Dr. Mach

Surgical lights with integrated SD/HD video cameras; video systems

Bavarian maker of operating and examination lights that offers cameras built into the light head for recording and transmitting the operative field.

Product page →Source checked

Sweden

Getinge

Tegris OR integration

Touchscreen platform that routes and records video up to 4K, streams live for teaching and consultation, and links to hospital systems via HL7 and DICOM.

Product page →Source checked

Germany

KARL STORZ

OR1 (OR1 NEO, OR1 AIR, AIDA documentation)

Integration system for controlling devices from the sterile field, managing 4K audio and video, documenting cases and streaming with two-way telestration.

Product page →Source checked

Japan

Olympus

EASYSUITE (ES-IP; earlier ENDOALPHA)

Modular procedure-room integration built around a digital hub that routes 4K video over IP, captures several sources and sends images to EHR and PACS.

Product page →Source checked

Japan

Sony

NUCLeUS

Vendor-neutral imaging platform that records, organises and distributes HD and 4K surgical video and stills across the hospital network and into patient records.

Product page →Source checked

Ireland

STERIS

HexaVue IP integration system

Network-based 4K system for capturing, displaying and distributing theatre video, with its hardware housed outside the room to cut cabling.

Product page →Source checked

USA

Stryker

iSuite with Connected OR operating system

Integrated theatre combining Stryker cameras, lights, booms, displays and a scalable 4K video-routing platform under one device-control system.

Product page →Source checked

Planning checklist for a new spine theatre

  1. Brief: Set out the spine case mix (deformity, MIS, endoscopy, robotics, intraoperative 3D) the room must serve before choosing its size. HBN 26: Facilities for surgical procedures, Volume 1 (NHS) ↗
  2. Brief: Put surgeons, anaesthetists, theatre staff, estates and infection control on the planning team from day one. HBN 26: Facilities for surgical procedures, Volume 1 (NHS) ↗
  3. Brief: In the US, check which edition of the FGI Guidelines (renamed FGI Codes from the 2026 edition) your state has adopted and design to it. FGI Guidelines / FGI Codes for Planning and Design – editions (Facility Guidelines Institute) ↗
  4. Design: Treat the 55 m² NHS standard theatre as a floor, and size up for spine work that can need up to seven instrument trolleys plus robot, camera and imaging. HBN 26: Facilities for surgical procedures, Volume 1 (NHS) ↗
  5. Design: Agree the ventilation concept early, with an ultra-clean canopy large enough to cover both the table and the trolley lay-up area. HTM 03-01: Specialised ventilation for healthcare premises (NHS England, 2021) ↗
  6. Design: In Germany, design and qualify theatre ventilation to DIN 1946-4, including the 2025 amendment A1. DIN 1946-4:2018-09 Ventilation in buildings and rooms of health care (DIN Media) ↗
  7. Room & building: Get the chosen imaging system's published room size from the maker (e.g. ARTIS pheno: ≥ 68 m² recommended, 35 m² technical minimum) and build to it. Siemens Healthineers – ARTIS pheno for the hybrid OR ↗
  8. Room & building: Confirm ceiling structural support height and clear height for booms, lights and ceiling-mounted imaging against the supplier's room drawing. Philips – Azurion 7 hybrid OR example room layout ↗
  9. Room & building: Check floor loading and transport routes (lifts, door widths, thresholds) for heavy mobile CT; Airo TruCT alone weighs 816 kg. Stryker – Airo TruCT ↗
  10. Room & building: HBN 26: Facilities for surgical procedures, Volume 1 (NHS) ↗
  11. Imaging & radiation: Appoint a radiation protection adviser early and have the shielding of walls, doors and windows calculated for the planned imaging workload. HSE L121: Working with ionising radiation – IRR17 Approved Code of Practice (2nd edn, 2018) ↗
  12. Imaging & radiation: In the US, base structural shielding design on NCRP Report No. 147. NCRP Report No. 147: Structural Shielding Design for Medical X-Ray Imaging Facilities (2004) ↗
  13. Imaging & radiation: In the EU, check the national law that transposes the Euratom Basic Safety Standards for staff dose limits and controlled areas. Council Directive 2013/59/Euratom (EU Basic Safety Standards) ↗
  14. Imaging & radiation: Fit X-ray warning lights above every theatre door and specify door gear rated for the weight of lead-lined leaves. HBN 26: Facilities for surgical procedures, Volume 1 (NHS) ↗
  15. Imaging & radiation: Set up a radiation safety programme with a named lead, staff dosimetry, and regular checks of aprons and mobile shields. AORN Guideline in Focus: Radiation Safety ↗
  16. Integration & IT: IEC 80001-1:2021 Application of risk management for IT-networks incorporating medical devices ↗
  17. Integration & IT: Agree electrical supply, back-up power and socket provision for every theatre system with the electrical engineer. HTM 06-01: Electrical services supply and distribution (NHS England) ↗
  18. Procurement: Ask each shortlisted supplier for its full site-planning data (weight, footprint, power, heat output, ceiling support) before signing; many publish none online. Philips – Azurion 7 hybrid OR example room layout (site-specific design via the supplier) ↗
  19. Commissioning: Require the installer's critical examination of every X-ray system, reviewed with the radiation protection adviser, before clinical use. Ionising Radiations Regulations 2017, regulation 32 (UK) ↗
  20. Commissioning: Validate the theatre ventilation and record the results before the first patient. HTM 03-01: Specialised ventilation for healthcare premises (NHS England, 2021) ↗

Emerging technology

13 Jan 2026The connected theatreCommercial

FDA clears Stryker Connected OR Hub with device and voice control

Stryker Endoscopy (FDA 510(k) K254014)

The clearance covers voice and remote control of compatible theatre devices such as cameras, light sources, insufflators and pumps, plus digital documentation. 'SDC4K' here is a Stryker product name, not the IEEE SDC standard.

Source →Source checked

1 Apr 2025The connected theatrePilot

GE HealthCare joins OR.NET to back the SDC device-connectivity standard

GE HealthCare / OR.NET e.V.

GE HealthCare became a member of OR.NET, the association behind SDC, the ISO/IEEE 11073 protocol that lets devices from different makers share data and be controlled across the theatre and intensive care. It said it wants to speed up the standard's completion and uptake.

Source →Source checked

2024-12The connected theatreResearch

Integration models for SDC-capable devices in an existing OR network

Reutlingen University (Current Directions in Biomedical Engineering)

Engineers compared three ways of adding SDC-capable devices to an established theatre network and tested the most flexible one by linking an electrosurgical unit to an OR light in a research theatre. They think the approach could carry over to other mixed-vendor set-ups.

Source →Source checked

18 Mar 2025AI in theatrePilot

KARL STORZ introduces Pathway.AI with Artisight and NVIDIA

KARL STORZ, Artisight, NVIDIA

Pathway.AI uses cameras and ambient listening in the theatre to automate routine workflow steps, such as alerting staff when a case ends or a room needs cleaning. Artisight is building it into KARL STORZ's OR1 integration platform; commercial availability was not stated.

Source →Source checked

12 Nov 2025Augmented and virtual realityCommercial

Augmedics gains FDA clearance for its X2 augmented-reality headset

Augmedics

X2 is a second-generation headset for the xvision Spine System, with roughly double the field of view and resolution, a detachable headlight and a tilting lens for seated or standing work. At announcement, delivery still depended on US FCC equipment authorisation.

Source →Source checked

8 Jul 2026Humanoid robots (research only)Research

Teleoperated humanoid robots remove gallbladders in live animals

UC San Diego (study published in Nature)

Surgeons used a remotely controlled humanoid robot, Surgie, built on a commercial humanoid, to perform two laparoscopic gallbladder removals in anaesthetised animals, one of them with two humanoids working together. The team reports frequent recalibration, longer operating times and control lag as problems still to solve.

Source →Source checked

27 Feb 2026Humanoid robots (research only)Research

Humanoid robots as first assistants in endoscopic surgery

Johns Hopkins University researchers (arXiv preprint)

A teleoperated humanoid held the endoscope steady throughout a cadaveric sinus procedure performed by an ENT surgeon. The authors judge the humanoid form feasible but list engineering changes needed before any clinical use.

Source →Source checked

Humanoid robots in theatre are research projects, not products: we track new demonstrations, trials and approvals each month.

Setting up for spine

Free guides to back-table and instrument set-up for spine cases are on For the Spine Team.

Coming next

Lights and booms · Neuromonitoring (see Neuromonitoring) · Instruments and sterilisation. Suggest a maker we have missed via Feedback; companies can use Corrections.

Head fixation and prone positioning

Skull clamps and pin head holders, prone head positioners, cervical traction tongs, and the safety guidance on head fixation and eye protection in prone spine surgery. Operating tables and frames are listed above. Makers are listed with what their own pages state; not an endorsement.

Skull clamps and head holders(5)
USA (Cincinnati, OH address on Integra MAYFIELD sell sheet)

MAYFIELD cranial stabilisation (skull clamps, pins, base units)

Integra LifeSciences

Skull clamps: MAYFIELD Metal, Mayfield 2, MAYFIELD Infinity XR2 Radiolucent; disposable, reusable and speciality skull pins; Standard Metal, Ultra and Ghost base units; MAYFIELD Spine Table System. Page states Ghost is 'Narrow and Radiolucent' (excluding the mounting post) and fits CT scanners, O-arms and C-arms.

Imaging
Radiolucent (Infinity XR2; Ghost excl. post); fits O-arm/C-arm/CT. No MRI/navigation statement on page.
Details

Note: Radiolucency statements only; the page makes no MRI or navigation-compatibility statement. Check the IFU for the specific model before iCT/iMRI use.

Product page →Source checked

USA

MAYFIELD Spine Table Adaptors (A2600R radiolucent, A2600M metal)

Integra LifeSciences

Connect MAYFIELD skull clamps and horseshoe headrests to speciality spine tables (Jackson Spine Table named) for cervical spine procedures; A2600R connects radiolucent clamps/horseshoes via XR2 swivel adaptor.

Imaging
Radiolucent option (A2600R).
Details

Note: Sell sheet (marketing); A2600M swivel adaptor may be required and is not included.

Product page →Source checked

Germany (Freiburg); US subsidiary in Cape Coral, FL

DORO Skull Clamp Radiolucent / DORO Skull Clamp Radiolucent for Spinal Frames

Black Forest Medical GmbH (formed 2019 by merger of pro med instruments and Feinmechanik GmbH; DORO brand)

3-pin rigid cranial fixation, completely metal-free clamp 'suitable for imaging procedures, using iCT or Angio'; slim spinal-frame version 'can be mounted to all established spinal OR tables and spinal frames'. Separate DORO LUCENT Brainlab navigation adaptor and iMRI cranial stabilisation system listed as related products.

Imaging
Radiolucent, metal-free; CT and angio imaging stated. MRI/navigation via separate products.
Details

Note: No MRI or navigation claim for these clamps themselves; MRI/navigation are separate products. Company history: https://blackforestmedical.com/company-history

Product page →Source checked

Brazil (inferred from company name and GS1 789 barcode prefix; not stated on pages opened)

Headfix HF02B / HF03B cranial fixation systems and pins

Micromar (Micromar Indústria e Comércio Ltda)

Cranial fixator for adult neurosurgery, compatible with most operating tables; aluminium/stainless steel construction; cranial fixation pins (MD0 series).

Imaging
None stated.
Details

Note: Only a marketplace listing (MedicalExpo) opened, no maker site. No radiolucency or MRI statement. Country not confirmed.

Product page →Source checked

Japan / USA (510(k) applicant address Beverly, MA; Japan not stated on pages opened)

Mizuho Radiolucent Head Frame / Multipurpose Head Frame (Sugita-type)

Mizuho (Mizuho America, Inc. for 510(k); MIZUHO CORPORATION in GUDID)

Four-point skull clamp with carbon-fibre structure (510(k) K955012, decision 12 Sep 1996); Multipurpose Head Frame components listed 'In Commercial Distribution' in GUDID.

Imaging
Radiolucent (carbon fibre) per 510(k) summary.
Details

Note: Regulatory records only; no maker product page opened. Old clearance; current product range unconfirmed.

Product page →Source checked

Prone head positioning(6)
USA (Union City, CA / Oceanside, CA)

ProneView Protective Helmet System

Mizuho OSI (exclusive worldwide distributor); manufactured by Dupaco, Inc.

Protective helmet, reflective mirror base ('continuous eye monitoring') and disposable contoured foam cushion inserts (S/M/L; adjustable and fixed-height helmets). States use on any general surgical table or Mizuho OSI spine top.

Imaging
None stated.
Details

Note: Brochure claims ('meets AORN guidelines', '3 million cases with no reported pressure-related blindness') are manufacturer statements, not independent evidence. No radiolucency statement.

Product page →Source checked

USA

C-Prone Head Positioner (Allen Medical, GSS-A-70300)

Baxter (Hillrom / Allen Medical Systems)

Positions and supports the head in a variety of procedures incl. spine; 'Skull clamps can be attached using adapters.'

Imaging
None stated.
Details

Note: Catalogue page has no radiolucency/mirror statements and no documents listed.

Product page →Source checked

Ireland (registered office Dublin) / USA

ELITE Prone Positioner (BF485)

STERIS

Gel patient positioner whose shape is described as 'ideal for spinal procedures'; not made with natural rubber latex.

Imaging
None stated.
Details

Note: Body/chest positioner rather than a dedicated head holder; check STERIS prone-accessory range for head pieces.

Product page →Source checked

USA (not stated on page; 'Inc.' only)

Prone Head Positioner with Arm Support (M10-082)

DeRoyal Industries, Inc.

Breathable high-density foam prone head positioner; 'Protects facial features when patient is placed in the prone position'; forearm support.

Imaging
None stated.
Details

Note: Indications, CE mark and latex fields blank on page.

Product page →Source checked

USA (not stated on page)

AliBlue Gel Prone Head Pad

AliMed

Polyurethane viscoelastic gel prone head pad (M and L) with ventilation-tube slots; neutral head position.

Imaging
None stated.
Details

Note: Retail product page; no radiolucency statement.

Product page →Source checked

Cervical traction tongs(3)

Few makers still show traction tongs on a current product page; several entries come from regulator records. Check availability with your supplier.

USA

Resolve Tongs / J Tongs (fibreglass skull traction tongs)

Össur Americas (formerly The Jerome Group)

Open tong design in non-conductive E-glass (fibreglass); 510(k) K071173 (25 May 2007) lists 'Compatible w/X-ray, CT, MR'. GUDID J Tong record: 'MR Conditional'.

Imaging
MR Conditional (GUDID); X-ray/CT/MR compatible (510(k)).
Details

Note: GUDID lists Össur J Tong and Resolve halo ring kits as 'Not in Commercial Distribution' since 28 Feb 2020 - probably no longer sold; confirm with Össur.

Record →Source checked

USA

Bremer Imaging Tongs - MRI model / Bremer tong pin set

DePuy Spine, LLC (Bremer brand, now DePuy Synthes)

510(k) K924606 (1993) 'Bremer Imaging Tongs-MRI Model'; GUDID Bremer tong pin set record.

Imaging
'MRI model' named in 1993 clearance; GUDID record has no MRI safety information.
Details

Note: GUDID: Bremer tong pin set 'Not in Commercial Distribution' since 8 Mar 2017 - historical only.

Record →Source checked

USA (Schaumburg, IL)

Gardner-Wells titanium traction tongs (sold under CareFusion, Millennium Surgical, Boss Instruments, Stealth Surgical, Prezio Health brands)

Instrumed International, Inc. (parent Avalign Technologies as of 2017)

Recall records for a lock nut and a replacement screw for titanium traction tongs used 'to immobilize a patient with a cervical spine injury'.

Imaging
Titanium (no MRI statement).
Details

Note: Source is a recall database (ICIJ), not a product page; date and reason of recall not stated. Confirms the manufacturer behind several Gardner-Wells brands but not current availability.

Record →Source checked

Safety guidance: head fixation and prone positioning(5)
USAregulator safety communication

FDA Safety Communication: Neurosurgical Head Holders (Skull Clamps) and Device Slippage (25 Feb 2016)

US Food and Drug Administration (copy hosted by Integra)

Over 1,000 slippage reports 2009-2016; inspect before/after each use, stability check, pin-site selection (avoid thin bone, orbit, vessels, prior craniotomy), pins near 90 degrees, torque per skull thickness, particular care with paediatric pins and torque; report events.

Details

Note: Copy of FDA communication on a manufacturer server.

Read →Source checked

USAprofessional society advisory

Practice Advisory for Perioperative Visual Loss Associated with Spine Surgery 2019 (Anesthesiology 2019;130(1):12-30)

American Society of Anesthesiologists Task Force with NANOS and SNACC

Preoperative risk, blood pressure, blood loss/fluids, vasopressors, head positioning (level or elevated, neutral, avoid direct eye pressure), staging, postoperative vision assessment.

Details

Note: Summary page opened (Guideline Central); Original: pubs.asahq.org Anesthesiology 130(1):12.

Read →Source checked

USAprofessional nursing guideline (summary)

AORN Guideline for Patient Positioning (2022 update) - 10 new practices

Association of periOperative Registered Nurses (AORN)

Prone/Trendelenburg vision-loss risk (Recs 5.1, 6.1); shoulder braces no longer recommended (Rec 5.7); pressure-injury guideline points (high-spec support surfaces, validated risk tool).

Details

Note: Summary article; full guideline is behind AORN membership.

Read →Source checked

Belgium (authors; not stated on page)peer-reviewed review

Thijs D, Menovsky T. The Mayfield skull clamp: a literature review of its complications and technical nuances for application. World Neurosurg 2021;151:102-109. doi:10.1016/j.wneu.2021.04.081

Peer-reviewed review

Complications rare but often serious and avoidable - mainly pin-related vascular injury and skull fracture; conceptual framework for clamp application.

Details

Note: Abstract only (aggregator page); cranial-focused but applies to clamp use in cervical spine surgery.

Read →Source checked

How we compile this page

Each area lists manufacturers alphabetically. We describe product lines in a few words from the maker's own pages. Inclusion is not an endorsement, and nobody pays to be listed. Positioning makers such as Bone Foam are listed with operating tables; skull clamps, prone head positioners and traction tongs have their own section.

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.

Spinal Frontiers is a trademark of NSpine GmbH.

Information only, summarised from third-party sources: not medical, legal, regulatory or financial advice. Full disclaimer.

© 2013 – 2026 NSpine Limited. Privacy notice.