The Food and Drug Administration issued 35 orthopedic- and spine-related 510(k) clearances in November, according to an FDA report.
1. Memometal Implants from Memometal Technologies.
2. Reliance Spinal Screw System from Reliance Medical Systems.
3. Exactech Equinox Fixed Angle Replicator Plate, Humeral Head-Short from Exactech.
4. SURESHOT Distal Targeting System from Smith & Nephew.
5. Life Spine Interspinous Fixation System from Life Spine.
6. Appliance, Fixation, Spinal Invertebral Body from Alphatec Spine.
7. Novation Crown Cup With Integrip Acetabular Shell, Cluster-Hole from Exatech.
8. Endoskeleton TO from Titan Spine.
9. Shapeloc-CL Soft Tissue Fastener, Shapeloc-ST Soft Tissue Fastener from MedShape Solutions.
10. Novation Femoral System from Exactech.
11. Kirschner Wires, Steinman Pins from Evergreen Orthopedic Research Lab.
12. Modification to Oasys System from Stryker Spine.
13. Locking Compression Plate from Changzhou Orthomed Medical Instruments.
14. Affiniti Total and Hemi-Shoulder System from Tornier.
15. Parcus PEEK CF Push-In Suture Anchor from Parcus Medical.
16. Exactech Bioloxdelta/Biolox Femoral Heads from Exactech.
17. Modification to Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
18. Viper F2 Facet Fixation System from DePuy Spine.
19. Choice Spine Starfire Pedicle Screw System from Choice Spine.
20. CD Horizon Spinal System from Medtronic Sofamor Danek.
21. MOUNTAINEER Oct Spinal System from DePuy Spine.
22. Series II X3 Large Diameter Acebaular Inserts from Stryker.
23. CSTS Screw from OrthoPro.
24. Special Orthopaedic Solutions Glenoid Shoulder Component from Howmedica.
25. Trinity Acetabular System from Corin U.S.A.
26. Locking Bone Screw from Changzhou Orthomed Medical Instruments.
27. DePuy Reclaim Revision Hip System from DePuy (Ireland).
28. Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw from Wright Medical Technology.
29. Emerge Medical Cannulated Screw Fixation System from Emerge Medical.
30. Conmed Linvatec Sequent Meniscal Repair Device from Conmed Linvatec.
31. Arrow Anatomical Shoulder System from Fournitures Hospitalieres Industries.
32. Conmed Altrus Thermal Tissue Fusion System from Conmed.
33. Axle Interspinous Fusion system from X-Spine Systems.
34. HTO Plating System from Aesculap Implant Systems.
35. Staxx XD System from Spine Wave.
Read the FDA 510(k) report on devices released in November.
Read other coverage on FDA approvals:
- 34 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in October
- 28 Orthopedic and Spine Device Receive FDA 510(k) Clearance in September
1. Memometal Implants from Memometal Technologies.
2. Reliance Spinal Screw System from Reliance Medical Systems.
3. Exactech Equinox Fixed Angle Replicator Plate, Humeral Head-Short from Exactech.
4. SURESHOT Distal Targeting System from Smith & Nephew.
5. Life Spine Interspinous Fixation System from Life Spine.
6. Appliance, Fixation, Spinal Invertebral Body from Alphatec Spine.
7. Novation Crown Cup With Integrip Acetabular Shell, Cluster-Hole from Exatech.
8. Endoskeleton TO from Titan Spine.
9. Shapeloc-CL Soft Tissue Fastener, Shapeloc-ST Soft Tissue Fastener from MedShape Solutions.
10. Novation Femoral System from Exactech.
11. Kirschner Wires, Steinman Pins from Evergreen Orthopedic Research Lab.
12. Modification to Oasys System from Stryker Spine.
13. Locking Compression Plate from Changzhou Orthomed Medical Instruments.
14. Affiniti Total and Hemi-Shoulder System from Tornier.
15. Parcus PEEK CF Push-In Suture Anchor from Parcus Medical.
16. Exactech Bioloxdelta/Biolox Femoral Heads from Exactech.
17. Modification to Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
18. Viper F2 Facet Fixation System from DePuy Spine.
19. Choice Spine Starfire Pedicle Screw System from Choice Spine.
20. CD Horizon Spinal System from Medtronic Sofamor Danek.
21. MOUNTAINEER Oct Spinal System from DePuy Spine.
22. Series II X3 Large Diameter Acebaular Inserts from Stryker.
23. CSTS Screw from OrthoPro.
24. Special Orthopaedic Solutions Glenoid Shoulder Component from Howmedica.
25. Trinity Acetabular System from Corin U.S.A.
26. Locking Bone Screw from Changzhou Orthomed Medical Instruments.
27. DePuy Reclaim Revision Hip System from DePuy (Ireland).
28. Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw from Wright Medical Technology.
29. Emerge Medical Cannulated Screw Fixation System from Emerge Medical.
30. Conmed Linvatec Sequent Meniscal Repair Device from Conmed Linvatec.
31. Arrow Anatomical Shoulder System from Fournitures Hospitalieres Industries.
32. Conmed Altrus Thermal Tissue Fusion System from Conmed.
33. Axle Interspinous Fusion system from X-Spine Systems.
34. HTO Plating System from Aesculap Implant Systems.
35. Staxx XD System from Spine Wave.
Read the FDA 510(k) report on devices released in November.
Read other coverage on FDA approvals:
- 34 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in October
- 28 Orthopedic and Spine Device Receive FDA 510(k) Clearance in September