The Food and Drug Administration granted 44 orthopedic and spine-related device clearances in December.
1. Perimeter C Spinal System from Medtornic Sofamor Danek.
2. Anodyne Anterior Cervical Plate System from CoreLink.
3. iUni Unicondylar Knee Replacement System from ConforMIS.
4. Aequalis Reversed Shoulder Prosthesis from Tornier.
5. Aequalis Humeral Nail from Tornier.
6. Stryker Customized Mandible Recon Plate Kit from Stryker.
7. CD Horizon Spinal System from Medtronic Sofamor Danek.
8. Staxx System from Spine Wave.
9. K7 Lumbar Spacers from K7.
10. Exoshape Femoral Soft Tissue Fastener from Medshape.
11. Restoris Multicompartmental Knee System from MAKO Surgical.
12. Smith & Nephew Patient Matched Cutting Blocks from Smith & Nephew.
13. Genesys Spine Apache IBFD Star Cervical System from Genesys Spine.
14. Clydesdale Spinal System from Medtronic Sofamor Danek.
15. Certex OCT Spinal Implant System from X-Spine Systems.
16. Vanguard XP Knee System from Biomet.
17. Genesys Spine Apache Lateral Lumbar Interbody Fusion System from Genesys Spine.
18. CrossCheck Plating System from Solana Surgical.
19. Mikron Spinal Fixation System from Mikron Makina Sanayi VE Ticaret.
20. Corin Metafix Hip System from Corin USA.
21. DePuy Synthes Spine DENS Access System from Synthes USA Products.
22. Corin MiniHip System from Corin USA.
23. Vitalite E Cross-Linked Polyethylene Acetabular Insert from Consensus Orthopedics.
24. Perfix Iliac Screw System from U&I.
25. Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation System from Stryker Spine.
26. Zimmer Distal Radius Plating System from Zimmer.
27. ST360 Degrees Spinal Fixation System from Zimmer Spine.
28. Arthrex iBalance TKA System from Arthrex.
29. M.U.S.T. Extension from Medacta International.
30. Arix Hand Locking System from Jeil Medical.
31. Aptus Cannulated Compression Screws from Medartis.
32. Axsos 3 TI Locking Plate System Line Extension from Stryker Trauma.
33. Struxxure Anterior Cervical Plate and Screws from Nexxt Spine.
34. Orthovis Preoperative Plan from Custom Orthopaedic Solutions.
35. Affix Next Gen Spinous Process Plate System from NuVasive.
36. Capstone Spinal System from Medtronic Sofamor Danek.
37. InFix Anterior Lumbar Spine from Zimmer Spine.
38. Velox Anterior Cervical Plate System from SpineCraft.
39. Loqteq Distal Dorsolateral Humerus Plate from aap Implantante.
40. Pioneer MaxFuse Vertebral Body Replacement Device from Pioneer Surgical Technology.
41. Reunion RSA Shoulder System from Howmedica Osteonics.
42. Monument Spacers from Globus Medical.
43. SureLock All-Suture Anchor With Inserter from Cayenne Medical.
44. Trochanteric Nails and ES Trochanteric Nails, Humeral Nails, Tibial Nails from Advanced Orthopaedic Solutions.
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