The Food and Drug Administration announced 44 spine- and orthopedic-related clearances in April.
1. Modified Distal Radius Plating System from Biomet.
2. Variax Clavical Hook Plate from Stryker Trauma.
3. N8tive ACL Anatomic Reconstruction System from ArthroCare.
4. Innesis PEEK Cervical Cage from BK Meditech.
5. CoRoent Small Interbody System from NuVasive.
6. Aleutian IBF System from K2M.
7. Dynasty Shell from Microport Orthopedics.
8. DePuy Global Unite Shoulder System from DePuy.
9. Variax 2 System from Stryker Trauma AG.
10. I.B.S. Snap-Off Screw/Solafix Snap-Off Screw from In2Bones SAS.
11. TSP Hip Fracture Plating System from Biomet.
12. Tornier Insite FT PEEK Knotless Suture Anchor from Tornier.
13. Medinaut Kyphoplasty System from Imedicom.
14. Locking Bone Plate Style 14, Metafix Locking Screw from Merete Medical.
15. Fragment Plate System from Skeletal Dynamics.
16. Abacus TM Spacer System from Spine Wave.
17. Baxano Surgical MIS Spinal System from Baxano Surgical.
18. Orthros Posterior Stabilization System from Camber Spine.
19. Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides from Materialise.
20. Streamline TL Spinal Fixation System from Pioneer Surgical Technology.
21. Renovis Tesera Trabecular Technology Acetabular Shell System from Renovis Surgical Technologies.
22. Proposed Optimus from Custom Spine.
23. Spineworks Anterior Lumbar Device from Spineworks.
24. Discoscopes, Cervical Endoscopes from RZ Medizintechnik GMBH.
25. Cervical Stand Alone System from Orthofix.
26. Picasso II MIS Spinal System from AccelSpine.
27. Cogent Med-LIF from Cogent Spine.
28. Intess Cervical Cage System from Kalitec Direct.
29. AIS ModuLIF VBR System from Aesculap Implant System.
30. Paralock Plating System/Tuffnek Screw from Paragon 28.
31. Zip MIS Interspinous Fusion System from Aurora Spine.
32. AnyPlus; ALIF PEEK Cages, PLIF PEEK Cages, T-PLIF PEEK Cages from GS Medical.
33. Mitek Arthroscopes from Medos International.
34. Mastergraft Putty, Mastergraft Strip from Medtornic Sofamor Danek.
35. Orthosorb LS from Biomet.
36. Juliet OL from Spineart.
37. Fortress Pedicle Screw System from Spineology.
38. Polaris Spinal System-Translation Screw from EBI.
39. Octane Elevate Spinal Implant System from Exactech.
40. Pinit Small Bone Fusion System from Arthrosurface.
41. Reliance Anterior Cervical Plate from Reliance Medical Systems.
42. Infinity Total Ankle System from Wright Medical Technology.
43. Anatomic PEEK PTC Cervical Fusion System from Medtronic Sofamor Danek.
44. General Spinal System from Tianjin Walkman Biomaterial.
More Articles on FDA Clearances:
44 Spine, Orthopedic Devices Receives FDA 510(k) Clearance in March
31 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in February
35 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in January