49 orthopedic devices receive FDA 510(k) clearance in November

Laura Dyrda -   Print  |

The FDA cleared 49 orthopedic devices in November 2019.


1. PFC Sigma Knee System from DePuy Orthopaedics.

2. Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head from Zimmer.

3. DePuy Corail AMT Hip Prosthesis from DePuy.

4. TDM Plate and Screw Systems from TDM.

5. Engage Partial Knee System from Engage UNI.

6. XIHPOS ZFUZE Interbody Fusion System from DiFusion Technologies.

7. World Knee Total Knee Systems from Signature Orthopaedics.

8. LongBow Ti from Life Spine.

9. Physica KR Liner and SMR Reverse Humeral Liner from LimaCorporate.

10. Copal Exchange G Hip and Knee Spacers from Heraeus Medical.

11. SmartSPACE Shoulder System from TechMah Medical.

12. SandShark Injectable Anchor System from Stimwave Technologies.

13. AEON-C Stand Alone System from Huvexel.

14. SAM IO Intraosseous Access System from SAM Medical Products.

15. Delta Multihole TT Pro Acetabular System from LimaCorporate.

16. Arthrex Nano SwiveLock Suture Anchor from Arthrex.

17. SMR TT Augmented Glenoid System from LimaCorporate.

18. OrthoGold from Tissue Regeneration Technologies.

19. ARIX Wrist System from Jeil Medical Corp.

20. NuVasive AttraX Putty from NuVasive.

21. Piper Go-IO Intraosseous Infusion System from Piper Access.

22. Peridot Intervertebral Body Fusion System from GBS Commonwealth.

23. Oryx Cervical Plate System from Innovasis.

24. iASSIST Knee System from Orthosoft.

25. AMIStem-P Short Neck from Medacta International.

26. 7D Surgical System from 7D Surgical.

27. Precice Plating System from NuVasive.

28. Conformis Hip System from Conformis.

29. Fitmore Hip Stem from Zimmer.

30. Cortina Lumbar Cage System from NeuroStructures.

31. Aegis Anterior Lumbar Plate System from Medos International SARL.

32. Aptus Wrist Arthrodesis Plates from Medartis.

33. DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile from Synthes USA.

34. Navigated Anterolateral Disc Prep Instruments from Medtronic Sofamor Danek.

35. Shoulder Innovations Total Shoulder System from Shoulder Innovations.

36. Streamline MIS Spinal Fixation System from Pioneer Surgical Technology.

37. VK100 Percutaneous Vertebral Augmentation System from BONWRx.

38. ARIX Cannulated Screw System from Jeil Medical.

39. NuVasive CoRoent Small Interlock System from NuVasive.

40. Axis Plating System from Extremity Medical.

41. VeriAx Foot from Stryker.

42. DePuy Synthes Trauma Screws from Synthes USA.

43. TranS1 AxiaLIF Plus System from TranS1.

44. Percus Knotless AP Suture Anchors from Parcus Medical.

45. Brainlab Compatible K2M Navigation Instruments from K2M.

46. GMA 2.0 Pedicle Screw System from Grafton Medical Alliance.

47. Pinnacle Duofix HA Acetabular Cup Prosthesis from DePuy Orthopaedics.

48. DePuy Corail AMT Hip Prosthesis from DePuy Orthopaedics.

49. Resorbable Mesh Device from SeaSpine Orthopedics.

More articles on orthopedic surgery:
8 DOJ investigations into illegal kickbacks in orthopedics in 2019
11 PE transactions in orthopedics in 2019
2 recent value-based partnerships for orthopedic procedures


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