The Food and Drug Administration issued 34 orthopedic- and spine-related 510(k) clearances in October, according to an FDA report.
1. Xiphos Interbody Fusion System from DiFusion Tehconlogies.
2. Zimmer Natural Nail System Retrograde Femoral Nails from Zimmer Holdings
3. Akro Vu Vidoescopic Carpal Tunnel Releases VCTR System from Skeletal Dynamics.
4. Caspian Spinal System from K2M.
5. Journey Unicondylar Tibial Baseplates from Smith & Nephew.
6. DePuy Pinnacle ALTRX Acetabular Liners from DePuy Orthopaedics.
7. Paradigm Interspinous Fusion Plate from Paradigm Spine.
8. Acumed Wrist Arthrodesis Plate System from Acumed.
9. Consensus CS2 Plus Acetabular Insert from Consensus Orthopedics.
10. Interfuse T Intervertebral Body Fusion Device from Vertebral Technologies.
11. Osteobridge IKA Intramedullary Knee Arthrodesis Rod Fixation System from Merete Medical GMBH.
12. Modification to the Expedium Spine System from DePuy Spine.
13. IO Fix Hand, IO Fix Foot, Extremity Medical Screw System from Extremity Medical.
14. Small Plateau Spacer System from Life Spine.
15. Kyphon Xpander II Inflatable Bone Tamp from Medtronic.
16. Sapphire Anterior Cervical Plate System from Spinal Elements.
17. KAPSS Spinal System from Robert Reid.
18. LDR Spine USA SpineTune TL Spinal System from LDR Spine USA.
19. Bio-Modular Reverse Shoulder from Biomet Manufacturing Corp.
20. Viper Spine System from DePuy Spine.
21. Contours VSP III Volar Plating System from Orthofix.
22. Intrafix Tibial Sheath from DePuy Mitek.
23. Pioneer Cannulated Screw System from Pioneer Surgical Technology.
24. Exatech GPS from Blue Ortho.
25. Bond Bone from M.I.S. Implants Technologies.
26. T2 XVBR 1.2 Spinal System from Medtronic Sofamor Danek.
27. ArthroCare Spartan PEEK Suture Implant System from ArthroCare Corp.
28. Vanguard 360 Revision Knee System form Biomet.
29. Pioneer Spinous Process Fusion Plate from Pioneer Surgical Technology.
30. Clavicle Locking Plate System from Newclip Technics.
31. Kyphon Anchor Facet Screw System from Medtronic.
32. FM-02 Bone Graft Substitute from Orthovita.
33. Speedfix Suture System from ArthroCare.
34. Arrowhead Fixation Device from Arrowhead Products.
Read the FDA 510(k) Clearance list.
1. Xiphos Interbody Fusion System from DiFusion Tehconlogies.
2. Zimmer Natural Nail System Retrograde Femoral Nails from Zimmer Holdings
3. Akro Vu Vidoescopic Carpal Tunnel Releases VCTR System from Skeletal Dynamics.
4. Caspian Spinal System from K2M.
5. Journey Unicondylar Tibial Baseplates from Smith & Nephew.
6. DePuy Pinnacle ALTRX Acetabular Liners from DePuy Orthopaedics.
7. Paradigm Interspinous Fusion Plate from Paradigm Spine.
8. Acumed Wrist Arthrodesis Plate System from Acumed.
9. Consensus CS2 Plus Acetabular Insert from Consensus Orthopedics.
10. Interfuse T Intervertebral Body Fusion Device from Vertebral Technologies.
11. Osteobridge IKA Intramedullary Knee Arthrodesis Rod Fixation System from Merete Medical GMBH.
12. Modification to the Expedium Spine System from DePuy Spine.
13. IO Fix Hand, IO Fix Foot, Extremity Medical Screw System from Extremity Medical.
14. Small Plateau Spacer System from Life Spine.
15. Kyphon Xpander II Inflatable Bone Tamp from Medtronic.
16. Sapphire Anterior Cervical Plate System from Spinal Elements.
17. KAPSS Spinal System from Robert Reid.
18. LDR Spine USA SpineTune TL Spinal System from LDR Spine USA.
19. Bio-Modular Reverse Shoulder from Biomet Manufacturing Corp.
20. Viper Spine System from DePuy Spine.
21. Contours VSP III Volar Plating System from Orthofix.
22. Intrafix Tibial Sheath from DePuy Mitek.
23. Pioneer Cannulated Screw System from Pioneer Surgical Technology.
24. Exatech GPS from Blue Ortho.
25. Bond Bone from M.I.S. Implants Technologies.
26. T2 XVBR 1.2 Spinal System from Medtronic Sofamor Danek.
27. ArthroCare Spartan PEEK Suture Implant System from ArthroCare Corp.
28. Vanguard 360 Revision Knee System form Biomet.
29. Pioneer Spinous Process Fusion Plate from Pioneer Surgical Technology.
30. Clavicle Locking Plate System from Newclip Technics.
31. Kyphon Anchor Facet Screw System from Medtronic.
32. FM-02 Bone Graft Substitute from Orthovita.
33. Speedfix Suture System from ArthroCare.
34. Arrowhead Fixation Device from Arrowhead Products.
Read the FDA 510(k) Clearance list.