54 spine, orthopedic devices receive FDA 510(k) clearances in February

Spinal Tech

The Food and Drug Administration cleared 54 spine- and orthopedic-related devices in February.

1. DePuy Attune Knee System — Cementless CR and PS Femoral Components from DePuy.

 

2. Patient-Specific Smiles Total Knee Replacement from Stanmore.

 

3. Alliance Spine RAAS Cranial Plating System from Alliance Partners.

 

4. Nautilus Spinal System and Solstice OCT System from Life Spine.

 

5. Life Spine Sacroiliac Joint Fixation System from Life Spine.

 

6. Aesculap OrthoPilot Next Generation from Aesculap Implant System.

 

7. Procotyl L-O Acetabular System from MicroPort Orthopedics.

 

8. NuVasive X-Core Expandable VBR System from NuVasive.

 

9. Talos-C Cervical Intervertebral Boy Fusion Devices from Medtronic Spine.

 

10. Magnify and Magnify-S Spacers from Globus Medical.

 

11. Spinal System from Eisertech.

 

12. Biomet Microfixation Thoracic Fixation System from Biomet Microfixation.

 

13. G7 Freedom and Offset Liners, Freedom Head, Size 32 from Biomet.

 

24. StaXx XD System from Spine Wave.

 

25. Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach from Stryker Orthopaedics.

 

26. Renovis S111 Lumbar Interbody Cage System from Renovis Surgical Technologies.

 

27. ACL Smart System from Smith & Nephew.

 

28. Vanguard 360 Revision Knee System from Biomet.

 

29. MIS Z-Pedicle Screw System from Z-Medical.

 

30. Scarlet AC-T Secured Anterior Cervical Cage from Spineart.

 

32. Ancora LLC Interbody Fusion Device from Frontier Medical Devices.

 

33. Palladian Lumbar Pedicle Screw System from Neurostructures.

 

34. Acumed Small Bone IM Nail System from Acumed.

 

35. Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Replacement from Zimmer Spine.

 

36. Progressive Orthopaedic Total Hip System from The Progressive Orthopaedic Company.

 

37. Nile Alternative Fixation from K2M.

 

38. CD Horizon Spinal System, Medtronic Navigated Reusable Instruments from Medtronic Sofamor Danek.

 

39. PedFuse Pedicle Screw System from SpineFrontier.

 

40. Extremity Medical Calcaneal Osteotomy Device from Extremity Medical.

 

41. Anax 5.5 Spinal System from U&I Corporation.

 

42. VERTEX Reconstruction System from Medtronic Sofamor Danek.

 

43. Exactech Ambassador from Exactech.

 

44. Navigated Vertex Select Instruments from Medtronic Sofamor Danek.

 

45. Kinetis Total Knee System from MAKO Surgical.

 

46. Zimmer Segmental System XT Components from Zimmer.

 

47. PASS LP Spinal System from Medicrea International.

 

48. Excia Total Hip System from Aesculap Implant Systems.

 

49. Micronail Distal Radius System from Wright Medial Technology.

 

50. SteriSpine PS Pedicle Screw from Safe Orthopaedics.

 

51. Klassic Knee System-Sombrero Patella from Total Joint Orthopedics.

 

52. Zimmer Periarticular Plating System from Zimmer.

 

53. Extremity Medical Suture Anchor from Extremity Medical.

 

54. CD Horizon Growth Rod Conversion Set from Medtronic Sofamor Danek.

 

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