36 orthopedic, spine devices receive FDA 510(k) clearance in April

Laura Dyrda -   Print  |

The FDA cleared 36 orthopedic and spine devices in April 2018.


1. Summit Hip System from DePuy Orthopaedics.

2. Corin Optimized Positioning System Plan from Corin USA.

3. Reform POCT System from Precision Spine.

4. Infinity Total Ankle System from Wright Medical.

5. Agile Nail from Orthofix.

6. Half Dome Posterior Lumbar Interbody System from Astura Medical.

7. Mercury Spinal System from Spinal Elements.

8. Unity Sacroiliac Joint Fixation System from Huvexel.

9. Enza-A Titanium ALIF from Camber Spine Technologies.

10. MySpine Pedicle Screw Placement Guides from Medacta International.

11. LigaPASS from Medicrea International.

12. SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device from SeaSpine.

13. A.L.P.S. Clavicle Plating System from Biomet.

14. UNiD Patient Specific 3D printed cage from Medicrea International.

15. Axis Anterior Cervical Plate System from Axis Orthopaedics.

16. Corin TriFit CF Hip System from Corin USA.

17. Genesys Spine Binary Lumbar Plate System from Genesys Spine.

18. Arthrex Univers Revers Modular Glenoid System from Arthrex.

19. Mediant Anterior Cervical Plating System from Intelligent Implant Systems.

20. OVOMotion Shoulder Arthroplasty System from Arthrosurface.

21. Rampart One Lumbar Interbody Fusion Device from Spineology.

22. Fibergraft BG Matrix Bone Graft Substitute from Prosidyan.

23. Medacta Shoulder System Short Humeral Diaphysis from Medacta International.

24. Cure Lumbar Plate System from Meditech Spine.

25. Creo Stabilization System from Globus Medical.

26. Navio Surgical System from Blue Belt Technologies.

27. InCore Lapidus System from Nextremity Solutions.

28. Axis 5.5 Lumbar pedicle Screw System from Axis Orthopaedics

29. Mazor X from Mazor Robotics.

30. Patriot Spinal Fixation System from Valorus Spine.

31. K2M Patient Specific Rods from K2M.

32. Focus Pedicle Screw System from Nvision Biomedical Technologies.

33. Precice Stryde System from NuVasive Specialized Orthopedics.

34. Stablyx Arthroplasty Implant System from Skeletal Dynamics.

35. World Knee System from Signature Orthopaedics.

36. Vertex Reconstruction System from Medtronic Sofamor Danek.

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