Here are 40 spine devices and technologies earning FDA clearances in 2025.
Note: This is not an exhaustive list.
1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a stand-alone equivalent to autografts in spine surgeries.
2. Orthopedic robotics company Corin earned FDA clearance for the ApolloHipX, a total replacement application designed for the Corin Apollo platform.
3. Spine devicemaker icotec earned FDA 510(k) clearance for its BlackArmor spine implants.
4. Ventris Medical earned FDA 510(k) clearance for its Backpack bone graft containment system.
5. The FDA cleared Spineart’s Perla TL application for use with eCential Robotics Op.nTM robotic navigation platform.
6. Medical device company Life Spine earned FDA clearance for its Gruve+ cervical plating system.
7. Life Spine earned FDA 510(k) clearance for its ProLift Pivot expandable spacer system.
8. Saluda Medical earned FDA approval for its biomarker-based automated patient programming platform used in spinal cord stimulation.
9. Tenon Medical earned FDA 510(k) clearance to use its Catamaran sacroiliac joint system for augmenting thoracolumbar fusion. With the new indication Catamaran can be used as a standalone treatment or to augment spinal fusion.
10. Aurora Spine earned FDA 510(k) clearance for its Aero facet fusion system. Aero is a minimally invasive system for facet joint-related pain or instability in levels C2 to S1.
11. Medivis has earned FDA clearance for its spine navigation platform, ahead of its commercial launch in the U.S. The platform can be used for both orthopedic and neurosurgery, utilizing augmented reality and artificial intelligence to provide surgeons holographic navigation across open and minimally invasive spine procedures.
12. LEM Surgical’s Dynamis robot for spine surgery earned FDA 510(k) clearance. The robot is the first multi-arm system for hard tissue surgery. Two arms are for surgical guidance, and one is for optical navigation. It supports a wide range of surgical instruments.
13. CGBIO, a South Korea-based company, earned the FDA’s investigational device exemption approval for its Novosis putty for spinal fusions.The bone graft incorporates rhBMP-2 and is designed to enhance high-density bone formation and minimize ectopic bone growth.
14. Eminent Spine earned FDA 510(k) clearance for its 3D-printed titanium pedicle screw system. The milestone makes it the first and only system of its kind to earn FDA clearance, and it is made from 100% 3D-printed titanium.
15. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions. The FDA’s 510(k) clearance was based on safety testing that found FlareHawk implants met established ASTM standards for MRI compatibility.
16. Expanding Innovations earned FDA clearance for its N-Gage lumbar plate system.
17. Cerapedics’ PearlMatrix P-15 peptide enhanced bone graft for lumbar spinal fusion earned FDA premarket approval. The FDA granted it a Class III drug-device combination product for single-level transforaminal lumbar interbody fusion in adults for degenerative disc disease.
18. Curiteva’s Inspire Trabecular PEEK standalone anterior lumbar interbody fusion system earned FDA 510(k) clearance.
19. Dymicron’s Triadyme-C artificial disc earned the FDA’s investigational device exemption approval. The IDE approval opens the door for a U.S. trial of the disc, which is designed for patients with degenerative disc disease.
20. Wenzel Spine received FDA clearance for panaSIa, an expandable sacroiliac fusion implant. The clearance marks the first FDA clearance of an expandable SI fusion implant.
21. The FDA cleared Rivanna’s SpineNav-AI image processing software and Accuro 3S diagnostic ultrasound system.
22. Spectrum Spine earned FDA 510(k) clearance for its family of lumbar cage implants.
23. SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber. The new 510(k) clearance adds indications for use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis.
24. Globus Medical earned FDA clearance for Excelsius XR.
25. Ruthless Spine earned FDA 510(k) clearance for the NavJam Jamshidi device.
26. Spinal Simplicity’s IntraLink injectable device for disc degradation earned the FDA’s breakthrough device designation.
27. Onward Medical has received FDA approval to begin a pivotal study of its Arc-IM system, an implantable neurostimulation therapy designed to treat blood pressure instability after spinal cord injury.
28. Brainlab earned FDA 510(k) clearance and launched its Spine Mixed Reality Navigation system.
29. Elevation Spine’s Saber-C earned FDA clearance for two-level cervical spinal fusion.
30. Tenon Medical’s SImmetry+ sacroiliac joint fusion system earned the FDA’s 510(k) clearance.
31. Centinel Spine received FDA premarket approval Oct. 14 for two-level use of its prodisc C Vivo and prodisc C SK cervical disc replacement devices.
32. Sync-AR earned FDA clearance for SyncAR Spine, a platform that combines XR tools and AI algorithms to support surgeons.
33. Astura Medical earned FDA 510(k) clearance for the Masada Sacral-Alar-Iliac system.
34. Augurex’s Spinestat diagnostic test earned the FDA’s breakthrough device designation.
35. CG MedTech earned FDA 510(k) approval for the Unispace lumbar spinal implant.
36. Augmedics earned FDA 510(k) clearance for X2, its new augmented reality headset for the xvision spine system.
37. Eminent Spine earned FDA 510(k) clearance for its 3D-printed titanium posterior sacroiliac joint system.
38. Switzerland-based Icotec received FDA clearance to expand use of its CMORE CT system in the cervicothoracic region.
39. Captiva Spine earned the FDA’s clearance for flat-panel C-arm calibrators and AI-assisted registration for its WatchTower navigation system.
40. Spinal Simplicity’s Minuteman G6 minimally invasive fusion device earned the FDA’s 510(k) clearance.
