The Food and Drug Administration issued 34 orthopedic- and spine-related 510(k) clearances in April, according to an FDA report.
1. Osseotite II from Biomet.
2. Consensus Biolox Delta Femoral Head from Consensus Orthopedics.
3. Expedium System, Viper System from DePuy Spine.
4. Vertex Reconstruction System, Vertex Select Reconstruction System from Medtronic Sofomor Danek.
5. Equinoxe Reverse Shoulder Compression Screw from Exactech.
6. Vault ALIF System from Spinal USA.
7. KneeAlign Sysem from OrthAlign.
8. BrainLab Knee from BrainLab G.
9. QuickDraw Convertible Fixation Implant System from Tornier.
10. Integrity Spinal Care System from Integra LifeSciences.
11. Mountaineer OCT Spinal System from DePuy Spine.
12. A-Channels Lumbat Spine Coils from Esaote S.P.A.
13. Smith & Nephew UltraBraid II Suture from Smith & Nephew.
14. LP Cage from Medyssey.
15. Tritanium Peri-Apatitie Acetabular Solid-Backed Shell from Howmedica Osteonics.
16. Taper Oxinium Femoral Head from Smith & Nephew.
17. DBX Bemineralized Bone Matrix Putty from Musculoskeletal Transplant Foundation.
18. ODRC-Dynamic Hip Screw System from Orthopaedic Device Research Center.
19. Smith & Nephew SureShot Distal Targeting System from Smith & Nephew.
20. NovaBone Putty-Bioactive Synthetic Bone Graft from NovaBone Products.
21. Lanx Spinal Fixation system from Lanx.
22. Continuum and Trilogy Integrated Taper IT Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated from Zimmer.
23. InFill Inervertebral Body Fusion Device from Pinnacle Spine Group.
24. Conserve Bio Foam Shell from Wright Medical.
25. 2.4 MM VA-LCP Volar Rim Distal Radius System from Synthes.
26. IFuse Implant System from SI-Bone.
27. Tripore TDD from OrthoGem Limited.
28. Revision Prosthesis from Smith & Nephew.
29. AVS Anchor-C Cervical Cage System from Stryker Spine.
30. Aequalis Ascend Modular Anatomic Shoulder System from Tornier.
31. PCL Tightrope from Arthrex.
32. Renaissance System from Mazor Robotics.
33. Cutting Edge Spine Interbody Fusion Device from Cutting Edge Spine.
34. Fortross Bone Void Filler from Pioneer Surgical.
Read the FDA report on April clearances.
Read Articles Related to FDA Clearances:
56 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
39 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in February
45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January
1. Osseotite II from Biomet.
2. Consensus Biolox Delta Femoral Head from Consensus Orthopedics.
3. Expedium System, Viper System from DePuy Spine.
4. Vertex Reconstruction System, Vertex Select Reconstruction System from Medtronic Sofomor Danek.
5. Equinoxe Reverse Shoulder Compression Screw from Exactech.
6. Vault ALIF System from Spinal USA.
7. KneeAlign Sysem from OrthAlign.
8. BrainLab Knee from BrainLab G.
9. QuickDraw Convertible Fixation Implant System from Tornier.
10. Integrity Spinal Care System from Integra LifeSciences.
11. Mountaineer OCT Spinal System from DePuy Spine.
12. A-Channels Lumbat Spine Coils from Esaote S.P.A.
13. Smith & Nephew UltraBraid II Suture from Smith & Nephew.
14. LP Cage from Medyssey.
15. Tritanium Peri-Apatitie Acetabular Solid-Backed Shell from Howmedica Osteonics.
16. Taper Oxinium Femoral Head from Smith & Nephew.
17. DBX Bemineralized Bone Matrix Putty from Musculoskeletal Transplant Foundation.
18. ODRC-Dynamic Hip Screw System from Orthopaedic Device Research Center.
19. Smith & Nephew SureShot Distal Targeting System from Smith & Nephew.
20. NovaBone Putty-Bioactive Synthetic Bone Graft from NovaBone Products.
21. Lanx Spinal Fixation system from Lanx.
22. Continuum and Trilogy Integrated Taper IT Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated from Zimmer.
23. InFill Inervertebral Body Fusion Device from Pinnacle Spine Group.
24. Conserve Bio Foam Shell from Wright Medical.
25. 2.4 MM VA-LCP Volar Rim Distal Radius System from Synthes.
26. IFuse Implant System from SI-Bone.
27. Tripore TDD from OrthoGem Limited.
28. Revision Prosthesis from Smith & Nephew.
29. AVS Anchor-C Cervical Cage System from Stryker Spine.
30. Aequalis Ascend Modular Anatomic Shoulder System from Tornier.
31. PCL Tightrope from Arthrex.
32. Renaissance System from Mazor Robotics.
33. Cutting Edge Spine Interbody Fusion Device from Cutting Edge Spine.
34. Fortross Bone Void Filler from Pioneer Surgical.
Read the FDA report on April clearances.
Read Articles Related to FDA Clearances:
56 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
39 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in February
45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January