The FDA issued 35 orthopedic- and spine-related 510(k) clearances in April, according to a report by the FDA.
1. Smith & Nephew Twinfix Ultra HA Surture Anchor from Smith & Nephew
2. Aegis & Aegis II Spinal System from Corentec
3. Stryker Sonicpin System from Howmedica Osteonics
4. Alexis Orthopaedic Wound Retractor from Applied Medical Resources
5. Minihip Stem from Corin U.S.A.
6. Smith & Nephew Footprint RCX PK Suture Anchor from Smith & Nephew
7. CAS Fixation Pin 3.2x180, 3.2x80, 3.2x150, from Orthosoft
8. Lanx Anterior Plating System from Lanx
9. Apex Arc Hip Stem from Omni Life Science
10. Alpha Orthopaedics AT3 System from Alpha Orthopaedics
11. Synthes Tomofix High Tibia Plate, small, from Synthes
12. DeRoyal Non-Locking Bone Fixation System from DeRoyal Industries
13. NCB Periprosthetic Femur Polyaxial Locking Plate from Zimmer
14. Modification to Trio+Spinal Fixation System from Stryker Spine
15. Zuma-C from Seaspine
16. Verilast Wear Claims for Legion Primary Knee System from Smith & Nephew
17. Synthes Air Pen Drive (APD) System from Synthes
18. Cormet Cementless Resurfacing Femoral Head from Corin USA
19. SLR-Plus Standard and Lateral Femoral Stems from Smith & Nephew
20. Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) from Lanx
21. Peanut Growth Control Plating System from EBI
22. Distalock Femoral Intramedullary Nail System from DGIMED Ortho
23. Smith & Nephew Hip Systems With HA from Smith & Nephew
24. Nanoss Bone Void Filler from Pioneer Surgical Technology
25. Tornier Surgical Mesh from Tornier
26. Diamondback Spinal System from Eminent Spine
27. Sureshot Tan Nails and Accessories from Smith & Nephew
28. Enduramesh Model 762.XXX from Lucero Medical
29. Crescent Spinal System from Medtronic Sofamor Danek
30. Zimmer Trabecular Metal Modular Acetabular System from Zimmer
31. Extremity Medical Screw System from Extremity Medical
32. TSRH Spinal System from Medtronic Sofamor Danek
33. Ringloc + Hybrid Acetabular System from Biomet
34. Axsos Locked Plating System Line Extension of 5mm Locking Inserts from Howmedica Osteonics
35. Gryphon T BR DS, T BR, P BR DS and P BR A Anchor with Orthocord from Depuy Mitek, a Johnson & Johnson Company
See the full list of April FDA clearances.
1. Smith & Nephew Twinfix Ultra HA Surture Anchor from Smith & Nephew
2. Aegis & Aegis II Spinal System from Corentec
3. Stryker Sonicpin System from Howmedica Osteonics
4. Alexis Orthopaedic Wound Retractor from Applied Medical Resources
5. Minihip Stem from Corin U.S.A.
6. Smith & Nephew Footprint RCX PK Suture Anchor from Smith & Nephew
7. CAS Fixation Pin 3.2x180, 3.2x80, 3.2x150, from Orthosoft
8. Lanx Anterior Plating System from Lanx
9. Apex Arc Hip Stem from Omni Life Science
10. Alpha Orthopaedics AT3 System from Alpha Orthopaedics
11. Synthes Tomofix High Tibia Plate, small, from Synthes
12. DeRoyal Non-Locking Bone Fixation System from DeRoyal Industries
13. NCB Periprosthetic Femur Polyaxial Locking Plate from Zimmer
14. Modification to Trio+Spinal Fixation System from Stryker Spine
15. Zuma-C from Seaspine
16. Verilast Wear Claims for Legion Primary Knee System from Smith & Nephew
17. Synthes Air Pen Drive (APD) System from Synthes
18. Cormet Cementless Resurfacing Femoral Head from Corin USA
19. SLR-Plus Standard and Lateral Femoral Stems from Smith & Nephew
20. Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) from Lanx
21. Peanut Growth Control Plating System from EBI
22. Distalock Femoral Intramedullary Nail System from DGIMED Ortho
23. Smith & Nephew Hip Systems With HA from Smith & Nephew
24. Nanoss Bone Void Filler from Pioneer Surgical Technology
25. Tornier Surgical Mesh from Tornier
26. Diamondback Spinal System from Eminent Spine
27. Sureshot Tan Nails and Accessories from Smith & Nephew
28. Enduramesh Model 762.XXX from Lucero Medical
29. Crescent Spinal System from Medtronic Sofamor Danek
30. Zimmer Trabecular Metal Modular Acetabular System from Zimmer
31. Extremity Medical Screw System from Extremity Medical
32. TSRH Spinal System from Medtronic Sofamor Danek
33. Ringloc + Hybrid Acetabular System from Biomet
34. Axsos Locked Plating System Line Extension of 5mm Locking Inserts from Howmedica Osteonics
35. Gryphon T BR DS, T BR, P BR DS and P BR A Anchor with Orthocord from Depuy Mitek, a Johnson & Johnson Company
See the full list of April FDA clearances.