Spine devices that won FDA nods in 2026

From navigation platforms to a motion-preserving cervical disc, here are 24 spine devices and technologies that earned FDA clearance or approval in 2026, as reported by Becker’s.

1. MRI2CT earned FDA 510(k) clearance in October for NextMR, an AI platform that creates 3D bone visualization of the spine from standard MRIs.
2. Xenix Medical received FDA 510(k) clearance in September to add its NanoACTIV Surface Technology to the screw shanks of its Riva modular pedicle screw system.
3. SI-Bone received FDA 510(k) clearance in September for its iFuse Granite Onyx System, a spinal fusion technology for patients with compromised bone. It’s the company’s first compromised-bone product intended for use outside the pelvis.
4. Xenix Medical earned FDA 510(k) clearance in September for its Riva Anchor spinopelvic fixation system, the first spinopelvic fixation system with an FDA nanotechnology designation.
5. SurGenTec received FDA 510(k) clearance in July for ION-L navigation instruments, designed to work with Medtronic’s StealthStation during posterior lumbar facet fusion.
6. Life Spine received FDA 510(k) clearance in June for its VersaLift Expandable Interbody System for transforaminal lumbar interbody fusion and posterior lumbar interbody fusion procedures. Its 6-millimeter starting height is among the smallest available for a TLIF expandable implant.
7. Mighty Oak Medical’s Acorn 3D presurgical correction planning software earned FDA clearance in June.
8. SurGenTec earned FDA 510(k) clearance this spring for its ION-L lumbar facet fixation system.
9. SurGenTec also earned FDA 510(k) clearance this spring for its ION-C navigation instruments.
10. Avatar Medical earned FDA 510(k) clearance this spring for Avatar Medical Vision, software that provides instant 3D image processing and surgical planning for orthopedics and neurosurgery.
11. Allevion Medical received FDA 510(k) clearance in April for its Vantage spinal decompression system, a fully disposable system for minimally invasive lumbar decompression.
12. Spectrum Spine’s next-generation BioBraille nanotechnology earned FDA 510(k) clearance in March. It uses laser etching to program nanofeatures onto implant surfaces.
13. VySpine earned FDA 510(k) clearance in March for its DiversiVy facet screw, designed to aid lumbosacral fusions.
14. Implanet’s 3D-printed Swingo anterior cervical cage earned FDA 510(k) clearance in March.
15. Synergy Spine Solutions earned FDA premarket approval in February for its Synergy Disc for one-level cervical disc replacement at C3 to C7. In its investigational device exemption study, the disc posted an 87.1% composite clinical success rate.
16. Medtronic earned FDA 510(k) clearance in February for its Stealth AXiS system, which combines planning, navigation and robotics in one spine platform designed for hospitals and ambulatory surgery centers.
17. The FDA granted premarket approval this winter to Empirical Spine’s LimiFlex dynamic sagittal tether, a motion-preserving system for lumbar spinal stenosis with grade 1 degenerative spondylolisthesis after decompression.
18. 4Web Medical’s SI joint truss system earned FDA 510(k) clearance this winter for sacroiliac joint fusion.
19. Spine Innovation’s Logic titanium implant system earned FDA 510(k) clearance this winter. The next-generation implant has a reduced profile and more than doubles in size during expansion.
20. SurGenTec earned FDA 510(k) clearance this winter for its ION-C facet fixation system for posterior cervical fusion, including indications for cervical pseudoarthrosis.
21. Medtronic’s Infuse bone graft earned expanded FDA premarket approval this winter for one- and two-level TLIF with PEEK and titanium cages. It’s now the only PMA-approved growth factor bone graft for anterior lumbar interbody fusion, oblique lumbar interbody fusion and TLIF.
22. Cresco Spine earned FDA 510(k) clearance in January for its spring distraction system for early-onset scoliosis, which previously received breakthrough device designation.
23. Proprio earned FDA clearance in January for the Picasso feature in its Paradigm AI platform, its fourth FDA clearance.
24. VySpine’s VyBrate VBR system earned FDA 510(k) clearance in January. It’s the first vertebral body replacement device on the market made with OsteoVy PEKK.

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