The Food and Drug Administration granted 35 orthopedic- and spine-focused 510(k) clearances in April. 1. iFuse Implant System from SI-BONE.
2. Streamline MIS Spinal Fixation System from Pioneer Surgical Technology.
3. Infinity Total Ankle System from Wright Medical Technology.
4. Vertex Reconstruction System from Medtronic Sofamor Danek.
5. TranS1 Lateral Interbody Fusion System from TranS1.
6. AccuLIF XL Cage from Coalign Innovations.
7. Phantom Fiber Biofiber Suture from Tornier.
8. Arthrex Fracture Plates from Arthrex.
9. Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty from Orthocon.
10. DePuy M-Spec 36MM Femoral Heads from DePuy Orthopaedics.
11. Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts from Cook Medical.
12. Sidekick EZ Frame External Fixation System from Wright Medical Technology.
13. Monster Screw System from Apogee OrthoSolutions.
14. Locking Bone Plates and Screws from Weigao Orthopaedic Device Company.
15. Capstone L Spinal System from Medtronic Sofamor Danek.
16. Spine Coil from USA ParaMed Medical Systems.
17. CD Horizon Spinal System from Medtronic Sofamor Danek.
18. TK1 Total Knee System form NovoSource.
19. Staxx IB System from Spinal Wave.
20. Foundation Knee System With Tin BN Coating Foundation from Encore Medical.
21. Synthes Small and Large External Fixation Systems from Synthes.
22. Heliocoil Suture Anchor With Regenesorb from Smith & Nephew.
23. S4 Spinal System from Aesculap Implant System.
24. Incite Anchored Cervical Interbody Device from Incite Innovation.
25. Lospa Total Knee Replacement from Corentec.
26. Aesculap CE Space XP from Aesculap Implant Systems.
27. Brigade Standalone System NuVasive from NuVasive.
28. Epicage Interbody Fusion Device from Alphatec Spine.
26. Newfix External Fixation System from Tecnologia Y Diseno Industrial.
27. Biosphere Bioactive Bone Graft Putty from Synergy Biomedical.
28. Double Engine Bone Plate and Screw Systems from Xiamen Double Engine Medical.
29. aap Cannulated Screw 2.0 from aap implantate.
30. NuVasvie NVM5 System from NuVasive.
31. Zavation Cervical Plate System from Zavation.
32. Vault ALIF System from Spinal USA.
33. Pantheon Spinal IBFD System from Pantheon Spinal.
34. Iris Anterior Cervical Plate from Life Spine.
More Articles on FDA Clearances:
31 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March
41 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in February
25 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in January