The Food and Drug Administration issued 36 orthopedic- and spine-related 510(k) clearances in February, according to an FDA report.
1. Polaris Spinal System from Biomet Spine.
2. Talon spinal System from Spine 360.
3. Modular Dual Mobility Liner, X3 Acetabular Insert from Howmedica Osteonics.
4. InterFuse DA Interbody Fusion System from Vertebral Technology.
5. Golden Gate Anterior Plate System from Ulrich GMBH & Co.
6. Cohesion Bone Cement form Teknimed.
7. CoRoent Interlock System from NuVasive.
8. Vitoss BA Boost Bioactive Bone Graft Substitute from Orthovita.
9. Medeor Matrix from Kensey Nash.
10. 5.5MM Spartan PEEK Suture Implant With #2 Magnum Wire, Punch Tap, Extraction Tool from ArthroCare.
11. Smith & Nephew SpatialFrame V4. 1 Web-Based Software from Smith & Nephew.
12. Leucadia Pedicle Screw System from Phygen.
13. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
14. Fuse PLIF Café from Advanced Medical Technologies.
15. HammerLoc TM Tibial Fixation Device from Biomet Sports Medicine.
16. Venus Basic Spinal Fixation System from L&K Biomed.
17. Venus Anterior Cervical Plate from Verticor.
18. Lanx Fusion System from Lanx.
19. 4CIS Vane Spine System from Solco Biomedical.
20. Bright Spine Galileo Spinal Spacer System from Bright Spine.
21. Skyline Anterior Cervical Plate System from Johnson & Johnson.
22. AXSOS Locked Plating 4.0MM Locking Inserts from Howmedica Osteonics.
23. PSL Anterior Cervical Plate System from Precision Surgery.
24. Trabecular Metal Femoral Cone Augments from Zimmer Trabecular Metal Technology.
25. OrthoStat Bone Hemostat Matrix Applicator from OrthoCon.
26. ArthroCare Parallax Contour Vertebral Augmentation Device from ArthroCare.
27. Spartek Variable Angle Pedicle Screw Posterior Fusion System from Spartek Medical.
28. Expedium Spine System, Moss Miami Spine System from Johnson & Johnson.
29. Rockwood Clavicle Pins from DePuy Orthopaedics.
30. Synthes Scout Vessel Guard from Synthes Spine.
31. Patient-Specific Vanguard Femoral Components from Biomet.
32. Piccolo Composite Plate System from N.M.B. Medical Applications.
33. ICuff Repair Plate, Anchor Bolt, 10MM Through 50MM from Shoulder Options.
34. Kyphon Xpede Bone Cement from Medtronic.
35. Corin Biolox Femoral heads from Corin USA.
36. Lanx Cervical Intervertebral Body Fusion System from Lanx.
Read full coverage of the medical devices cleared in February by the FDA.
Read other coverage on orthopedic and spine device clearances:
- 45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January
- 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December
1. Polaris Spinal System from Biomet Spine.
2. Talon spinal System from Spine 360.
3. Modular Dual Mobility Liner, X3 Acetabular Insert from Howmedica Osteonics.
4. InterFuse DA Interbody Fusion System from Vertebral Technology.
5. Golden Gate Anterior Plate System from Ulrich GMBH & Co.
6. Cohesion Bone Cement form Teknimed.
7. CoRoent Interlock System from NuVasive.
8. Vitoss BA Boost Bioactive Bone Graft Substitute from Orthovita.
9. Medeor Matrix from Kensey Nash.
10. 5.5MM Spartan PEEK Suture Implant With #2 Magnum Wire, Punch Tap, Extraction Tool from ArthroCare.
11. Smith & Nephew SpatialFrame V4. 1 Web-Based Software from Smith & Nephew.
12. Leucadia Pedicle Screw System from Phygen.
13. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
14. Fuse PLIF Café from Advanced Medical Technologies.
15. HammerLoc TM Tibial Fixation Device from Biomet Sports Medicine.
16. Venus Basic Spinal Fixation System from L&K Biomed.
17. Venus Anterior Cervical Plate from Verticor.
18. Lanx Fusion System from Lanx.
19. 4CIS Vane Spine System from Solco Biomedical.
20. Bright Spine Galileo Spinal Spacer System from Bright Spine.
21. Skyline Anterior Cervical Plate System from Johnson & Johnson.
22. AXSOS Locked Plating 4.0MM Locking Inserts from Howmedica Osteonics.
23. PSL Anterior Cervical Plate System from Precision Surgery.
24. Trabecular Metal Femoral Cone Augments from Zimmer Trabecular Metal Technology.
25. OrthoStat Bone Hemostat Matrix Applicator from OrthoCon.
26. ArthroCare Parallax Contour Vertebral Augmentation Device from ArthroCare.
27. Spartek Variable Angle Pedicle Screw Posterior Fusion System from Spartek Medical.
28. Expedium Spine System, Moss Miami Spine System from Johnson & Johnson.
29. Rockwood Clavicle Pins from DePuy Orthopaedics.
30. Synthes Scout Vessel Guard from Synthes Spine.
31. Patient-Specific Vanguard Femoral Components from Biomet.
32. Piccolo Composite Plate System from N.M.B. Medical Applications.
33. ICuff Repair Plate, Anchor Bolt, 10MM Through 50MM from Shoulder Options.
34. Kyphon Xpede Bone Cement from Medtronic.
35. Corin Biolox Femoral heads from Corin USA.
36. Lanx Cervical Intervertebral Body Fusion System from Lanx.
Read full coverage of the medical devices cleared in February by the FDA.
Read other coverage on orthopedic and spine device clearances:
- 45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January
- 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December