The Food and Drug Administration issued 49 orthopedic- and spine-related 510(k) clearances in December, according to an FDA report.
1. NuVasive Spherx II-Mas Deformity Spinal System from NuVasive.
2. Concorde Curve System from DePuy Spine.
3. Renovo Suture Anchors, Renovo SS & PEEK Products from Core Essences Orthopaedics.
4. Laminoplasty Plating System from Aesculap Implant System.
5. Consensus Taperset Hip System from Consensus Orthopedics.
6. Evolve EPS Ortholoc from Wright Medical Technology.
7. BioPro Polar Head from BioPro.
8. Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper from Zimmer.
9. Klassic HD Hip System from Total Joint Orthopedics.
10. Patriot Transcontinental M Spacers from Globus Medical.
11. Merete Locking Bone Plate System II from Merete Medical.
12. S. 100 Pedicle Screw System from Renovis Surgical Technologies.
13. Skeletal Dynamics Sterilization Trays from Skeletal Dynamics.
14. Viper System, Expedium System from DePuy Spine.
15. Arcos Interlocking Distal Stems from Biomet.
16. The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates from Howmedica Osteonics.
17. Suspension Clavicle Fracture Fixation System from Suspension Orthopaedic Solutions.
18. Optigen Total Knee System from U&I.
19. Suspension Acromioclaviclar (AC) Repair System from Suspension Orthopaedic Solutions.
20. Hip Sextant Instrument System from Surgical Planning Associates.
21. 2.4MM VA-LCP Dorsal Distal Radius Plates from Synthes.
22. Prevision Hip System With Recon Ring from Aesculap Implant Systems.
23. DePuy Attune Knee System from DePuy Orthopaedics.
24. Genesys Spine Interbody Fusion System from Genesys Spine.
25. Apex Spine System With COCR Rods from SpineCraft.
26. Lima-Lio SMR Shoulder System from Lima LTO.
27. Exactech Equinoxe R. UHMWPE Posterior Augment Pegged Glenoids from Exactech.
28. Trabecular Metal Tibial Cone Augments from Zimmer Trabecular Metal Technologies.
29. InBone Total Ankle System from Wright Medical Technology.
30. Simmetry Sacroiliac Joint Fusion System from Zyga Technology.
31. DePuy Global Unite Shoulder System from DePuy.
32. Contours Lapidus Plating System from Orthofix.
33. Vu CPOD Intervertebral BODU Fusion Device from Musculoskeletal Clinical Regulators.
34. Posterior Lateral Plates from DePuy Orthopaedics.
35. Novel III Spinal Fixation and Adjustable Bridge System from Medyssey Co.
36. Cervical Standalone Intervertebral Body Fusion Device from Theken Spine.
37. Synthes Zero-P from Synthes Spine.
38. Interia Pedicle Screw System from Nexxt Spine.
39. Enduro Knee System from Aesculap Implant Systems.
40. Mini and Micro Fragment Reconstruction System from NeoOrtho Productos Ortopedicos.
41. RHead Radial Head Extended Stems from Small Bone Innovations.
42. Medacta Total Hip Prosthesis System from Medacta International.
43. The Ascension Movement Great Toe System Total Arthroplasty from Ascension Orthopaedics.
44. Highly Cross-Linked Vitamin E. UHMWPE Tibial Inserts from Encore Medical.
45. Anterior Approach Hip Surgery Instruments from Wright Medical Technology.
46. Arthrex Universe II Shoulder Prosthesis from Arthrex.
47. TSRH Spinal System from Medtronic Sofamor Danek.
48. ACL Tightrope Double Bundle from Arthrex.
49. Zenius Spinal System from Medyssey Co.
Read the FDA report on orthopedic and spine device approvals for December.
Read other coverage on FDA 510(k) Clearance:
- 34 Orthopedic and Spine Devices Receive FDA Clearance in October
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November
1. NuVasive Spherx II-Mas Deformity Spinal System from NuVasive.
2. Concorde Curve System from DePuy Spine.
3. Renovo Suture Anchors, Renovo SS & PEEK Products from Core Essences Orthopaedics.
4. Laminoplasty Plating System from Aesculap Implant System.
5. Consensus Taperset Hip System from Consensus Orthopedics.
6. Evolve EPS Ortholoc from Wright Medical Technology.
7. BioPro Polar Head from BioPro.
8. Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper from Zimmer.
9. Klassic HD Hip System from Total Joint Orthopedics.
10. Patriot Transcontinental M Spacers from Globus Medical.
11. Merete Locking Bone Plate System II from Merete Medical.
12. S. 100 Pedicle Screw System from Renovis Surgical Technologies.
13. Skeletal Dynamics Sterilization Trays from Skeletal Dynamics.
14. Viper System, Expedium System from DePuy Spine.
15. Arcos Interlocking Distal Stems from Biomet.
16. The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates from Howmedica Osteonics.
17. Suspension Clavicle Fracture Fixation System from Suspension Orthopaedic Solutions.
18. Optigen Total Knee System from U&I.
19. Suspension Acromioclaviclar (AC) Repair System from Suspension Orthopaedic Solutions.
20. Hip Sextant Instrument System from Surgical Planning Associates.
21. 2.4MM VA-LCP Dorsal Distal Radius Plates from Synthes.
22. Prevision Hip System With Recon Ring from Aesculap Implant Systems.
23. DePuy Attune Knee System from DePuy Orthopaedics.
24. Genesys Spine Interbody Fusion System from Genesys Spine.
25. Apex Spine System With COCR Rods from SpineCraft.
26. Lima-Lio SMR Shoulder System from Lima LTO.
27. Exactech Equinoxe R. UHMWPE Posterior Augment Pegged Glenoids from Exactech.
28. Trabecular Metal Tibial Cone Augments from Zimmer Trabecular Metal Technologies.
29. InBone Total Ankle System from Wright Medical Technology.
30. Simmetry Sacroiliac Joint Fusion System from Zyga Technology.
31. DePuy Global Unite Shoulder System from DePuy.
32. Contours Lapidus Plating System from Orthofix.
33. Vu CPOD Intervertebral BODU Fusion Device from Musculoskeletal Clinical Regulators.
34. Posterior Lateral Plates from DePuy Orthopaedics.
35. Novel III Spinal Fixation and Adjustable Bridge System from Medyssey Co.
36. Cervical Standalone Intervertebral Body Fusion Device from Theken Spine.
37. Synthes Zero-P from Synthes Spine.
38. Interia Pedicle Screw System from Nexxt Spine.
39. Enduro Knee System from Aesculap Implant Systems.
40. Mini and Micro Fragment Reconstruction System from NeoOrtho Productos Ortopedicos.
41. RHead Radial Head Extended Stems from Small Bone Innovations.
42. Medacta Total Hip Prosthesis System from Medacta International.
43. The Ascension Movement Great Toe System Total Arthroplasty from Ascension Orthopaedics.
44. Highly Cross-Linked Vitamin E. UHMWPE Tibial Inserts from Encore Medical.
45. Anterior Approach Hip Surgery Instruments from Wright Medical Technology.
46. Arthrex Universe II Shoulder Prosthesis from Arthrex.
47. TSRH Spinal System from Medtronic Sofamor Danek.
48. ACL Tightrope Double Bundle from Arthrex.
49. Zenius Spinal System from Medyssey Co.
Read the FDA report on orthopedic and spine device approvals for December.
Read other coverage on FDA 510(k) Clearance:
- 34 Orthopedic and Spine Devices Receive FDA Clearance in October
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November