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Regulatory Watch

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Recalls and safety notices for spine devices, FDA clearances and approvals, CE marks under the EU MDR, and regulation news, each with a link to the official source.

August to October 2026Checked 6 November 2026
9 recalls and safety notices this period, for 8 spine devices, newest first (two notices concern the same navigation spheres). Always check the regulator's notice and your hospital's device safety officer before acting.
  • 22 Oct 2026 · Stryker Spine (US): Field safety notice for ES2 percutaneous system K-wire in Germany
  • 4 Sep 2026 · Northern Digital (NDI) / Medtronic Navigation: UK field safety notice for navigation marker spheres
  • 2 Sep 2026 · Medos International (Johnson & Johnson MedTech / DePuy Synthes): J&J halts use of VELYS robotic-assist stations over unintended arm movement
  • 21 Aug 2026 · SI-BONE: SI-BONE recalls iFuse TORQ screws after packaging seal failures
  • 19 Aug 2026 · SeaSpine (Orthofix): SeaSpine recalls Mariner deformity screw heads over thread-depth defect
  • 18 Aug 2026 · Cadwell Industries: Cadwell recalls IOMAX neuromonitoring module over stray-current fault
  • 12 Aug 2026 · Medtronic Sofamor Danek: Medtronic recalls Grafton DBM batch after donor tested positive for Clostridium
  • 3 Aug 2026 · Innovasis: Innovasis recalls undersized anti-torque instrument for Vector screws

Medicine and gene therapy safety (1)

Safety news on medicines and gene therapies that spine teams meet in their patients. Kept separate from the device recall counts below.

6 Nov 2026SafetyUSFDA safety communicationGene therapy

FDA investigates tumours after Zolgensma gene therapy for SMA

The FDA is investigating postmarketing reports of tumours in children treated with Zolgensma. Some reports show tumours caused by the product itself: the gene therapy's vector DNA had inserted next to or inside the cancer gene GLI1. Reported tumours involved the brain, spinal cord and nerves, the spinal and paraspinal regions, and the kidney. The FDA says the benefits still outweigh the risks for approved uses, and that treated patients and trial participants should be monitored for tumour formation.

Details
Company
Novartis Gene Therapies
Product
Zolgensma (intravenous) and Itvisma (intrathecal), onasemnogene abeparvovec, AAV9 gene therapy for spinal muscular atrophy
FDA (6 Nov 2026)
Three cases involved GLI1-associated tumours. In two, the tumour tissue contained Zolgensma vector DNA integrated into the patient's genome, upstream of or within GLI1. In the third, the mechanism is still under investigation. The FDA is evaluating whether regulatory action is needed and is reviewing the prescribing information (which already lists a theoretical risk of tumours from vector integration) and Novartis's long-term follow-up studies. The risk applies to Itvisma as well (same vector and construct; approved 24 Nov 2025 for patients aged 2 and over); no tumour has been reported after Itvisma so far.
Novartis (statement of 5 Nov 2026)
More than 6,000 patients have received Zolgensma since approval in 2019. Novartis has received 9 reports of tumours in treated patients. Two show evidence of vector DNA integration; both patients were treated and remain under monitoring. Novartis says it notified health authorities in each case. We found the statement through SMA Europe; we did not find it on novartis.com as of 7 Nov.
UK National MDT for Zolgensma (4 Nov 2026, via SMA UK)
Three of the nine tumours have been tested: two are linked to Zolgensma and one appears unrelated. Routine care and follow-up should stay the same, and no additional scans, tests or monitoring are needed at this time. Families with concerns should contact their neuromuscular team.
Europe and Switzerland
As of 7 Nov 2026 we found no public statement from the EMA, the MHRA or Swissmedic. SMA Europe says regulators are assessing the cases.
Earlier published case
Retson et al., Molecular Therapy 2023: a low-grade epithelioid intramedullary tumour at the conus (T12), 14 months after treatment; the authors found no evidence that vector integration caused it, but the test was limited by very little tumour DNA.
For spine teams
Reported tumours include spinal and paraspinal sites, and many treated children are seen by spine teams for scoliosis. Follow the FDA and your national guidance; report any tumour in a treated patient to Novartis Gene Therapies and to your regulator (US: 1-833-828-3947 or FDA MedWatch).

FDA safety communication, 6 Nov 2026 →
Novartis statement via SMA Europe, 5 Nov 2026 →
UK National MDT update via SMA UK, 4 Nov 2026 →
Retson et al., Mol Ther 2023 (PMID 37598295) →Sources checked

Full briefing in Safety in Focus: sources, summary and what is unknown →

Recalls (7)

2 Sep 2026RecallsUSFDA Class II recall

J&J halts use of VELYS robotic-assist stations over unintended arm movement

A software fault in the robotic controller may move the arm unexpectedly during bone preparation or instrument positioning; users of the 29 US stations were told to stop using and quarantine them, while the navigation and camera stations can stay in use. Initiated in late July and posted by FDA on 2 September; the station is cleared under a spine navigation and robotic-assistance 510(k).

Details
Company
Medos International (Johnson & Johnson MedTech / DePuy Synthes)
Device
VELYS Enabling Tech Robotic-Assist Station (REF 451611001)
Type
FDA Class II recall (Z-3088-2026), initiated 23 Jul 2026, posted 2 Sep 2026; device cleared as spine navigation and robotic assistance (510(k) K233228)

FDA Medical Device Recalls database →Source checked

Page for this item →

31 Aug 2026RecallsUSFDA Class II recall

Medtronic recalls navigation marker spheres over tracking risk

Variation in the reflective coating may stop the navigation camera detecting and tracking the spheres; more than 14,000 units were distributed in the US and abroad. Unused stock is to be quarantined and returned; the root cause is still under investigation.

Details
Company
Medtronic Navigation
Device
NDI Passive Spheres (REF 8801071, 8801074, 8801075) and passive biopsy needle kit (REF 9733068)
Type
FDA Class II recall (Z-0194-2027 to Z-0197-2027)

FDA Medical Device Recalls database →Source checked

Page for this item →

21 Aug 2026RecallsUSFDA Class II recall

SI-BONE recalls iFuse TORQ screws after packaging seal failures

Pelvic fixation screws failed tube-packaging seal-integrity testing, so sterility cannot be assured; about 100 units were shipped to nine US states. SI-BONE's chief medical officer contacted affected surgeons directly.

Details
Company
SI-BONE
Device
iFuse TORQ Implant System (cat. 10055T, 10060T, 10065T, 10080T, 11580T)
Type
FDA Class II recall (Z-0146-2027; 510(k) K203247)

FDA Medical Device Recalls database →Source checked

Page for this item →

19 Aug 2026RecallsUSFDA Class II recall

SeaSpine recalls Mariner deformity screw heads over thread-depth defect

Some Mariner deformity polyaxial heads were made with a proximal thread depth outside the design specification; 270 units in 18 US states are affected. Hospitals are told to stop using the lots, quarantine and return them via Orthofix.

Details
Company
SeaSpine (Orthofix)
Device
Mariner Deformity Extended Polyaxial Head, Attached Gimbal, 12 mm (REF MD1-300010-12)
Type
FDA Class II recall (Z-3226-2026; 510(k) K211606)

FDA Medical Device Recalls database →Source checked

Page for this item →

18 Aug 2026RecallsUSFDA Class II recall

Cadwell recalls IOMAX neuromonitoring module over stray-current fault

A defective circuit board, introduced after a supplier change, may deliver unintended stimulation or leakage current to the patient; 23 units went to the US and 15 other countries including Spain, Italy, Belgium and Switzerland.

Details
Company
Cadwell Industries
Device
IOMAX Cortical Module (190296-200), intraoperative neuromonitoring
Type
FDA Class II recall (Z-0141-2027; 510(k) K162199)

FDA Medical Device Recalls database →Source checked

Page for this item →

12 Aug 2026RecallsUSFDA Class II recall

Medtronic recalls Grafton DBM batch after donor tested positive for Clostridium

A donor-record review found the source bone tested positive for Clostridium butyricum, so one Grafton batch (38 units across two records) is being withdrawn despite irradiation and passed sterility tests. Unused product is to be returned and patients already implanted watched for signs of infection.

Details
Company
Medtronic Sofamor Danek
Device
Grafton DBM (Orthoblend, Paste) demineralised bone matrix, batch A62881
Type
FDA Class II recall (Z-0137-2027, Z-0138-2027; 510(k) K042707, K043048, K051188, K051195)

FDA Medical Device Recalls database →Source checked

Page for this item →

3 Aug 2026RecallsUSFDA Class II recall

Innovasis recalls undersized anti-torque instrument for Vector screws

Five anti-torque instruments may be undersized and fail to engage the tulip and rod during final tightening, which could delay surgery. Initiated in May but only posted by FDA on 3 August.

Details
Company
Innovasis
Device
Anti-torque instrument LS-749, Vector Pedicle Screw System
Type
FDA Class II recall (Z-2859-2026)

FDA Medical Device Recalls database →Source checked

Page for this item →

Safety notices (2)

22 Oct 2026Safety noticesDEField safety notice

Field safety notice for ES2 percutaneous system K-wire in Germany

BfArM listed an urgent field safety notice for the blunt nitinol K-wire used with the ES2 percutaneous pedicle screw system.

Details
Company
Stryker Spine (US)
Device
ES2 Spinal System Nitinol K+-Wire Blunt
Type
Urgent FSN (BfArM ref 49141/26)

BfArM field safety notices →Source checked

Page for this item →

4 Sep 2026Safety noticesUKfield safety notice

UK field safety notice for navigation marker spheres

The MHRA published the manufacturer's field safety notice for NDI passive reflective spheres in its 31 August–4 September list, mirroring the US recall over spheres that may not be reliably tracked by optical navigation cameras. The FSN itself is dated September 2026; the date given here is the end of the MHRA listing week. France's ANSM lists a lot recall of the same spheres (R2626613, 8 Sep 2026).

Details
Company
Northern Digital (NDI) / Medtronic Navigation
Device
NDI Passive Spheres (models 8801071, 8801074, 8801075)
Type
FSN (MHRA ref 40709365)

MHRA Field Safety Notices list →Source checked

Page for this item →

FDA decisions (24)

21 Oct 2026FDA decisionsUS510(k)

Alphatec clears additions to its Calibrate expandable interbody rangeNew · week 1

Alphatec's Calibrate MAX and Calibrate CCX interbody systems, with and without NanoTec surface, were cleared as lumbar fusion devices, also coded as vertebral body replacement devices.

Details
Company
Alphatec Spine
Device
Calibrate MAX and CCX interbody systems, including NanoTec versions
Type
510(k) K262646 (MAX; MQP)

FDA 510(k) database →Source checked

Page for this item →

19 Oct 2026FDA decisionsUS510(k)

FDA clears an updated 7D Surgical navigation systemNew · week 1

A further 510(k) for the 7D Surgical image-guided navigation system was cleared as an orthopaedic stereotaxic instrument. The FDA record does not set out what changed or the cleared indications.

Details
Company
7D Surgical
Device
7D Surgical System (10-0001)
Type
510(k) K260403 (OLO)

FDA 510(k) database →Source checked

Page for this item →

14 Oct 2026FDA decisionsUS510(k)

SurGenTec clears a lumbar decompression kitNew · week 1

A kit for lumbar decompression was cleared under the arthroscope category, with manual rongeurs as a secondary product code. The FDA record does not give its indications.

Details
Company
SurGenTec
Device
Vantage Lumbar Decompression Kit
Type
510(k) K263208 (HRX; HAE)

FDA 510(k) database →Source checked

Page for this item →

13 Oct 2026FDA decisionsUS510(k)

FDA clears 3D-printed titanium posterior cervical implant

Providence announced clearance of a porous, 3D-printed titanium version of its CORUS posterior cervical stabilisation implant for cervical degenerative disc disease.

Details
Company
Providence Medical Technology
Device
CORUS Posterior Cervical Stabilization System 3D-T
Type
510(k) (number not given in announcement)

Becker's Spine Review →Company or trade press source

Page for this item →

9 Oct 2026FDA decisionsUS510(k)

CarboFix clears navigated instruments for its carbon-fibre cervical implants

Navigated instruments for use with CarboFix's radiolucent carbon-fibre/PEEK cervical implants were cleared as stereotaxic accessories.

Details
Company
CarboFix Orthopedics
Device
CarboClear Cervical Navigated Instruments
Type
510(k) K263154 (OLO)

FDA 510(k) database →Source checked

Page for this item →

2 Oct 2026FDA decisionsUS510(k)

Spinal Simplicity clears updated interspinous plates and SI implants

A single 510(k) covered several Minuteman spinous-process fusion plates and the company's Patriot and Liberty lateral sacroiliac joint implants.

Details
Company
Spinal Simplicity
Device
Minuteman MIS fusion plates; Patriot SI and Liberty SI Lateral implant systems
Type
510(k) K261607 (PEK; OUR)

FDA 510(k) database →Source checked

Page for this item →

30 Sep 2026FDA decisionsUS510(k)

Brainlab clears updated spine planning, navigation and alignment software

Brainlab received 510(k) clearance for version 3.0 of its spine planning software together with its spine and trauma navigation and spinal alignment applications.

Details
Company
Brainlab
Device
Spine Planning 3.0; Spine & Trauma Navigation; Alignment System Spine
Type
510(k) K262257 (OLO)

FDA 510(k) database →Source checked

Page for this item →

30 Sep 2026FDA decisionsUS510(k)

Pre-shaped rods matched to pelvic incidence cleared for MIS use

Spinal Alignment Solutions received clearance for minimally invasive rods pre-contoured according to the patient's pelvic incidence.

Details
Company
Spinal Alignment Solutions
Device
SAS MIS Pelvic Incidence Rods
Type
510(k) K263172 (NKB)

FDA 510(k) database →Source checked

Page for this item →

29 Sep 2026FDA decisionsUS

Breakthrough designation for blood test predicting scoliosis progression

VB Spine announced FDA Breakthrough Device Designation for a six-microRNA blood test, developed at CHU Sainte-Justine, that aims to estimate which AIS patients are at risk of severe curve progression. Validation so far rests on a small 116-patient study.

Details
Company
VB Spine
Device
ScolimiR-3D blood test for adolescent idiopathic scoliosis
Type
Breakthrough Device Designation

SPINEMarketGroup (company announcement) →Company or trade press source

Page for this item →

24 Sep 2026FDA decisionsUS510(k)

Carlsmed adds a cervical plate to its personalised implant range

Carlsmed, known for patient-specific aprevo interbody devices, received clearance for its corra anterior cervical plating system.

Details
Company
Carlsmed
Device
corra cervical plating system
Type
510(k) K262149 (KWQ)

FDA 510(k) database →Source checked

Page for this item →

23 Sep 2026FDA decisionsUS510(k)

SI-BONE clears iFuse Granite Onyx for fixation beyond the pelvis

SI-BONE's Granite Onyx system was cleared under the pedicle screw product code, which trade press reports as the company's first fusion implant aimed at compromised bone outside the pelvis.

Details
Company
SI-BONE
Device
iFuse Granite Onyx Implant System
Type
510(k) K262067 (NKB; OLO)

FDA 510(k) database →Source checked

Page for this item →

14 Sep 2026FDA decisionsUS510(k)

Xenix clears nanotextured surface on RIVA screws and SI anchor

Xenix Medical's RIVA pedicle screw system and RIVA Anchor sacroiliac/spinopelvic fixation were cleared with its NanoACTIV surface treatment on the implants.

Details
Company
Xenix Medical
Device
RIVA Posterior Fixation and RIVA Anchor Sacroiliac Fixation systems with NanoACTIV surface
Type
510(k) K262193 (NKB; KWQ, OLO, OUR)

FDA 510(k) database →Source checked

Page for this item →

11 Sep 2026FDA decisionsUS510(k)

Magnesium-based bone void fillers cleared

Bone Solutions received clearance for two magnesium-based bone void filler products classed as calcium-compound fillers.

Details
Company
Bone Solutions
Device
Mg OSTEOREVIVE; Mg OSTEOCRETE
Type
510(k) K262230 (MQV; MBP, OIS)

FDA 510(k) database →Source checked

Page for this item →

11 Sep 2026FDA decisionsUS510(k)

Innovasis wins nano-scale surface claim for its HA-titanium cages

Innovasis received clearance that adds a nano-scale surface designation to three hydroxyapatite-titanium interbody product lines.

Details
Company
Innovasis
Device
AxTiHA stand-alone ALIF, TxTiHA and HAtetracell-C cervical interbody systems
Type
510(k) K262025 (OVD)

FDA 510(k) database →Source checked

Page for this item →

9 Sep 2026FDA decisionsUSPMA

prodisc C Nova cleared for two-level cervical use

FDA approved a PMA supplement expanding the indication of Centinel Spine's prodisc C Nova cervical disc from single-level to two-level use.

Details
Company
Centinel Spine
Device
prodisc C Nova
Type
PMA supplement P070001/S031

FDA PMA database →Source checked

Page for this item →

4 Sep 2026FDA decisionsUS510(k)

SMAIO gains US clearance for patient-specific pre-bent rods

The French company's KHEIRON posterior fixation system was cleared including the K-ROD, a rod contoured to the individual patient's surgical plan.

Details
Company
S.M.A.I.O
Device
KHEIRON Spinal Fixation System with patient-specific K-ROD
Type
510(k) K262828 (NKB; KWP)

FDA 510(k) database →Source checked

Page for this item →

4 Sep 2026FDA decisionsUS510(k)

AI software that builds CT-like spine bone images from MRI cleared

MRI2CT announced 510(k) clearance for NextMR, software that generates CT-like 3D bone views of the spine from standard MRI.

Details
Company
MRI2CT
Device
NextMR
Type
510(k) K260525 (FDA decision 4 Sep 2026; announced 7 Oct 2026)

SPINEMarketGroup (company announcement) →Company or trade press source

Page for this item →

28 Aug 2026FDA decisionsUS510(k)

Spineart's PERLA TL screws cleared for robot-assisted placement on Op.n

The two companies announced 510(k) clearance of the PERLA TL application, which lets PERLA TL open and MIS pedicle screws be placed using eCential's Op.n navigation and robotic-assistance platform. FDA's database shows the clearance was granted on 29 July, a month before the announcement.

Details
Company
Spineart / eCential Robotics
Device
PERLA TL app for the eCential Op.n navigation and robotic platform
Type
510(k) K261205 (OLO; FDA decision 29 July 2026, announced 28 August)

BioAlps (company announcement) →Company or trade press source

Page for this item →

24 Aug 2026FDA decisionsUS510(k)

SurGenTec clears lateral SI joint fusion system

SurGenTec's TiLink-L sacroiliac joint fusion system was cleared, with navigation listed as a secondary product code.

Details
Company
SurGenTec
Device
TiLink-L SI Joint Fusion System
Type
510(k) K261381 (OUR; OLO)

FDA 510(k) database →Source checked

Page for this item →

20 Aug 2026FDA decisionsUS510(k)

Remex clears universal instruments for its spine navigation system

Taiwan-based Remex received clearance for universal navigated instruments that extend its spine navigation system.

Details
Company
Remex Medical
Device
Remex Spine Surgery Navigation – Universal Instruments
Type
510(k) K262506 (OLO)

FDA 510(k) database →Source checked

Page for this item →

20 Aug 2026FDA decisionsUS510(k)

Spineart clears SCALA TL lumbar interbody device

Spineart received 510(k) clearance for its SCALA TL lumbar interbody fusion device.

Details
Company
Spineart
Device
SCALA TL
Type
510(k) K261049 (MAX)

FDA 510(k) database →Source checked

Page for this item →

18 Aug 2026FDA decisionsUS510(k)

L&K Biomed clears expandable cervical cage

The Korean company's BluEX expandable cervical interbody cage received a Special 510(k) clearance.

Details
Company
L&K Biomed
Device
BluEX Cervical Expandable Cage System
Type
510(k) K262489 (ODP)

FDA 510(k) database →Source checked

Page for this item →

10 Aug 2026FDA decisionsUSPMA

FDA approves Spineart's BAGUERA C cervical disc for one or two levels

FDA granted premarket approval for the BAGUERA C artificial disc for reconstruction at one or two contiguous levels from C3 to C7 in patients with radiculopathy or myelopathy after failed conservative care. A post-approval study protocol was approved on 22 September.

Details
Company
Spineart
Device
BAGUERA C Cervical Disc Prosthesis
Type
PMA P250042 (original approval)

FDA PMA database →Source checked

Page for this item →

3 Aug 2026FDA decisionsUS510(k)

Elevation Spine clears expandable stand-alone ALIF cage

Elevation Spine's SABER-XA, an expandable anterior lumbar interbody device with integrated fixation, received 510(k) clearance; the company also cleared a SABER-C line extension in September (K263049).

Details
Company
Elevation Spine
Device
SABER-XA expandable ALIF system
Type
510(k) K261408 (OVD)

FDA 510(k) database →Source checked

Page for this item →

CE marks (MDR) (3)

7 Oct 2026CE marks (MDR)EU

Navient spine and cranial navigation transitions to EU MDR

Toronto-based CKI announced MDR certification for its Navient navigation system, previously sold under the old Directive, which offers 2D fluoroscopy-based and CT/MRI-to-fluoro registration for spine.

Details
Company
ClaroNav Kolahi (CKI)
Device
Navient image-guided navigation system and instruments
Type
EU MDR certificate (notified body not stated)

SPINEMarketGroup (company announcement) →Company or trade press source

Page for this item →

3 Sep 2026CE marks (MDR)EUCE mark

Globus brings Excelsius3D imaging to Europe and the UK

Globus announced CE marking of Excelsius3D, a mobile cone-beam CT, fluoroscopy and radiography unit that can work with the ExcelsiusGPS robot, opening sales in the EU and UK. The announcement did not state the notified body.

Details
Company
Globus Medical
Device
Excelsius3D intraoperative imaging system
Type
CE mark (regulation and notified body not stated)

SPINEMarketGroup (company announcement) →Company or trade press source

Page for this item →

10 Aug 2026CE marks (MDR)EU

HumanTech adds fenestrated reduction screws with full VENUS range under MDR

German maker HumanTech Spine extended its VENUS system with cannulated, fenestrated reduction screws and reported that the whole VENUS range, and its quality management system, now hold MDR certification.

Details
Company
HumanTech Spine
Device
VENUS posterior stabilisation system (incl. cannulated fenestrated reduction screws, VENUS nano)
Type
EU MDR certification (notified body not stated)

SPINEMarketGroup →Company or trade press source

Page for this item →

Regulation news (1)

8 Oct 2026Regulation newsEU

Notified bodies stake out position on MDR revision

Team-NB published a statement on the planned revision of the EU device regulations, calling for a risk-based approach that protects notified-body capacity to avoid certification bottlenecks for SMEs and innovators. The statement does not say where the legislative process stands.

Details
Company
Team-NB (European notified bodies association)
Device
EU MDR/IVDR framework
Type
EU policy (MDR/IVDR revision)

Team-NB →Company or trade press source

Page for this item →

Other (4)

29 Oct 2026OtherUS/DE/FRFDA Class II recall

Stryker electromagnetic navigation pointer recalled in the US, Germany and France (spine use not confirmed)New · week 1

FDA posted a Class II recall on 29 October because the pointer tube may fracture at a laser-welded joint, and loose parts could fall out while the device is inside the patient; 513 units were distributed worldwide, including the UK and Germany. BfArM (25 Sep, ref. 43648/26) and ANSM (5 Oct, R2628768) had already listed action on the same pointer. The FDA record ties it to Stryker's cranial guidance 510(k) and does not mention spine, so we list it here rather than among spine recalls.

Details
Company
Stryker Leibinger (Stryker)
Device
Precision Pointer Electromagnetic (8000-050-001)
Type
FDA Class II recall (Z-0314-2027), initiated 24 Sep 2026, posted 29 Oct 2026; 510(k) K212194 (Q Guidance System with Cranial Guidance Software); earlier BfArM FSN (43648/26) and ANSM lot recall (R2628768)

FDA Medical Device Recalls database →Source checked

Page for this item →

21 Oct 2026OtherUK

Great Britain will keep accepting CE-marked devices indefinitely

After a spring consultation, the government confirmed that CE-marked devices, including spinal implants and surgical equipment, can continue to be placed on the GB market long term, with UKCA remaining the domestic route. A separate statutory instrument will update UKCA requirements.

Details
Company
UK Government / MHRA
Device
All CE-marked medical devices and IVDs
Type
UK policy (CE recognition)

GOV.UK (MHRA press release) →Source checked

Page for this item →

19 Oct 2026OtherUK

MHRA sets out closer FDA alignment and AI agenda at AdvaMed

The MHRA used AdvaMed to promote its 2030 strategy, including wider reliance on decisions by trusted regulators such as FDA, a planned Centre for AI and Digital Health and a US liaison post; no implementation dates were given.

Details
Company
MHRA
Device
Medical devices and AI as a medical device
Type
UK policy

GOV.UK (MHRA press release) →Source checked

Page for this item →

25 Aug 2026OtherUS

New Medicare MS-DRGs for patient-specific lumbar fusion from 1 October

The FY2027 inpatient rule created MS-DRGs 523–525 and new ICD-10-PCS codes for fusions using custom-made, anatomically designed interbody devices, effective 1 October 2026, as reported by manufacturers.

Details
Company
CMS (US Centers for Medicare & Medicaid Services)
Device
Custom-made, virtually designed interbody fusion devices
Type
US payment policy (FY2027 IPPS final rule)

SPINEMarketGroup (DeGen Medical statement) →Company or trade press source

Page for this item →

How we compile this page

We sweep the FDA recall and device databases, MHRA, BfArM, Swissmedic and ANSM notices, Health Canada, TGA, SAHPRA, INFARMED and the Egyptian Drug Authority, the Latin American regulators ANVISA, COFEPRIS, ANMAT and INVIMA, and company announcements for spine devices each week. Recalls and safety notices are always listed first on the home page. This page is a pointer to the official notice, not a substitute for it.

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