41 orthopedic, spine devices receive FDA 510(k) clearance in January

Spinal Tech

The FDA cleared 41 orthopedic-and spine-related devices in January.


1. II-Type Intervertebral Spacer from Paonan Biotech.

2. NEST Interbody System form Paonan Biotech.

3. VariLift-LX Interbody Fusion system, VariLift-C Interbody Fusion System from Wenzel Spine.

4. Responsive Arthroscopy Suture Anchor from Responsive Arthroscopy.

5. Responsive Arthroscopy Wedge Push-In Suture Anchors from Responsive Arthroscopy.

6. Avenue P Cage System from Zimmer Biomet Spine.

7. Reliance Lumbar IBF System from Reliance Medical Systems.

8. Ossio Pin Product Family from Ossio.

9. Pinehurst Anterior Cervical Plate System from Signature Orthopaedics.

10. Bodycad Unicompartmental Knee System from bodycad Laboratories.

11. Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow from Zimmer Biomet.

12. Imboki Knee Instrument System from Signature Orthopaedics.

13. Prostep Mica Screw System from Wright Medical Technology.

14. AQrate Robotic Assistance System from Globus Medical.

15. FlareHawk Interbody Fusion System from Integrity Implants.

16. TiWave-L Porous Titanium Lumbar Cage from Kalitec Medical.

17. Tyber Medical PT Interbody Spacer from Tyber Medical.

18. Cervical Spacer from Additive Implants.

19. Whistler Modular Pedicle Screw System from Evolution Spine.

20. 4CIS Pinehurst Anterior Cervical Plate System from Solco Biomedical.

21. OsteoCool RF Ablation System from Medtronic Sofamor Danek.

22. Catalyst CSR Press-Fit Humeral Components from Catalyst OrthoScience.

23. Freedom Ultra-Congruent CR Tibial Liner from Maxx Orthopedics.

24. Choice Spine Navigation System from Choice Spine.

25. M.U.S.T. Mini Extension from Medacta International.

26. SI-Restore Sacroiliac Joint Fixation System from Biofusion.

27. CD Horizon Spinal System from Medtronic Sofamor Danek USA.

28. Rosa Knee System from Orthosoft.

29. Hoffmann LRF System from Stryker.

30. Europa Pedicle Screw System from MiRus.

31. Additive Orthopaedics Patient Specific 3D Locking Lattice Plates from Additive Orthopaedics.

32. Mobio Total Knee System Posterior Stabilized Tibial Inserts, Mobio Total Knee System Patellar Component from b-One Ortho Corp.

33. Moto Partial Knee System from Medacta International.

34. CervAlign Anterior Cervical Plate System from Pioneer Surgical Technology.

35. VLIFT-s Vertebral Body Replacement System from Stryker Spine.

36. Zimmer Segmental System Proximal Femoral Component from Zimmer Biomet.

37. Raven Lumbar Plate System from Choice Spine.

38. HammerToe Compression System from Paragon 28.

39. T2 Stratosphere Expandable Corpectomy System from Medtronic Sofamor Danek.

40. O-Scan from Esaote.

41. Aequalis PerFORM Reverse Glenoid, Aequalis PerFORM + Reversed Glenoid from Tornier.

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