Spinal Frontiers · Medtech & Innovation · Product Developments
A neutral monthly overview of what is new in spine products, by product area.
Everything new this period, sorted by product area rather than by company: launches, FDA and CE decisions, newly published patents, and recalls and safety notices (in red). Areas and companies are in alphabetical order. This is an overview, not a comparison or a ranking.
Listings are a selection made at NSpine's editorial discretion and are not exhaustive. Inclusion is not an endorsement, and omission implies nothing.
Every spine recall and safety notice in this period, from Regulatory Watch.
BfArM listed an urgent field safety notice for the blunt nitinol K-wire used with the ES2 percutaneous pedicle screw system.
BfArM field safety notices →Source checked
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).
MHRA Field Safety Notices list →Source checked
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).
FDA Medical Device Recalls database →Source checked
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.
FDA Medical Device Recalls database →Source checked
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.
FDA Medical Device Recalls database →Source checked
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.
FDA Medical Device Recalls database →Source checked
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.
FDA Medical Device Recalls database →Source checked
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.
FDA Medical Device Recalls database →Source checked
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.
FDA Medical Device Recalls database →Source checked
Medtronic Sofamor Danek
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.
Source →Source checked
Bone Solutions
Bone Solutions received clearance for two magnesium-based bone void filler products classed as calcium-compound fillers.
Source →Source checked
Kyocera Medical Technologies, Inc. (USA)
Carlsmed
Carlsmed, known for patient-specific aprevo interbody devices, received clearance for its corra anterior cervical plating system.
Source →Source checked
Centinel Spine
FDA approved a PMA supplement expanding the indication of Centinel Spine's prodisc C Nova cervical disc from single-level to two-level use.
Source →Source checked
Providence Medical Technology
Providence announced clearance of a porous, 3D-printed titanium version of its CORUS posterior cervical stabilisation implant for cervical degenerative disc disease.
Source →Company or trade press source
Spineart
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.
Source →Source checked
Globus Medical
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.
Source →Company or trade press source
MRI2CT
MRI2CT announced 510(k) clearance for NextMR, software that generates CT-like 3D bone views of the spine from standard MRI.
Source →Company or trade press source
VB Spine
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.
Source →Company or trade press source
Innovasis
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.
Source →Source checked
Stryker Spine (US)
BfArM listed an urgent field safety notice for the blunt nitinol K-wire used with the ES2 percutaneous pedicle screw system.
Source →Source checked
Amplify Surgical, Inc. (USA)
Atec Spine, Inc. (formerly Alphatec Spine) (USA)
Atec Spine, Inc. (formerly Alphatec Spine) (USA)
Globus Medical, Inc. (USA)
Shukla Medical (USA)
Shukla Medical (USA)
Spinal Elements, Inc. (USA)
Warsaw Orthopedic, Inc. (USA; Medtronic)
Warsaw Orthopedic, Inc. (USA; Medtronic)
Alphatec Spine
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.
Source →Source checked
Elevation Spine
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).
Source →Source checked
Innovasis
Innovasis received clearance that adds a nano-scale surface designation to three hydroxyapatite-titanium interbody product lines.
Source →Source checked
L&K Biomed
The Korean company's BluEX expandable cervical interbody cage received a Special 510(k) clearance.
Source →Source checked
Spineart
Spineart received 510(k) clearance for its SCALA TL lumbar interbody fusion device.
Source →Source checked
4WEB Medical
Aesculap AG (Germany; B. Braun)
Alphatec Spine
Globus Medical, Inc. (USA)
Globus Medical, Inc. (USA)
Globus Medical, Inc. (USA)
Globus Medical, Inc. (USA)
Globus Medical, Inc. (USA)
Hassan Razian (France, individual applicant)
Hassan Razian (France, individual)
Johnson & Johnson (DePuy Synthes)
Life Spine, Inc. (USA)
Life Spine, Inc. (USA)
Spinal Elements, Inc. (USA)
Warsaw Orthopedic, Inc. (USA; Medtronic)
Cadwell Industries
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.
Source →Source checked
SeaSpine (Orthofix)
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.
Source →Source checked
HumanTech Spine
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.
Source →Company or trade press source
S.M.A.I.O
The French company's KHEIRON posterior fixation system was cleared including the K-ROD, a rod contoured to the individual patient's surgical plan.
Source →Source checked
Spinal Alignment Solutions
Spinal Alignment Solutions received clearance for minimally invasive rods pre-contoured according to the patient's pelvic incidence.
Source →Source checked
Biedermann Technologies (Germany)
Biedermann Technologies (Germany)
Biedermann Technologies GmbH & Co. KG (Germany)
Biedermann Technologies GmbH & Co. KG (Germany)
Biedermann Technologies GmbH & Co. KG (Germany)
Globeride (Japan), maker of Daiwa fishing tackle
Globus Medical, Inc. (USA)
Globus Medical, Inc. (USA)
Janez Mohar (Slovenia)
Mazor Robotics Ltd. (Israel; Medtronic)
Medos International Sàrl (Switzerland; Johnson & Johnson MedTech/DePuy Synthes)
Medtronic
Medtronic
Medtronic
Spinal Simplicity, LLC (USA)
Spine-Tech Inc. and Takai Corporation (Japan)
Warsaw Orthopedic, Inc. (USA; Medtronic)
Warsaw Orthopedic, Inc. (USA; Medtronic)
SI-BONE
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.
Source →Source checked
SI-BONE
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.
Source →Source checked
Spinal Simplicity
A single 510(k) covered several Minuteman spinous-process fusion plates and the company's Patriot and Liberty lateral sacroiliac joint implants.
Source →Source checked
SurGenTec
SurGenTec's TiLink-L sacroiliac joint fusion system was cleared, with navigation listed as a secondary product code.
Source →Source checked
Xenix Medical
Xenix Medical's RIVA pedicle screw system and RIVA Anchor sacroiliac/spinopelvic fixation were cleared with its NanoACTIV surface treatment on the implants.
Source →Source checked
Life Spine, Inc. (USA)
Life Spine, Inc. (USA)
Spinal Simplicity
SurGenTec
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.
Source →Source checked
Drawn from Regulatory Watch, Patent Watch and AI & Emerging Tech. Spinal cord stimulators are tracked here for readers of Pain Medicine when there is news. A granted patent or a clearance does not mean a product is on the market. Companies can ask for a factual correction via Corrections.
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