The Food and Drug Administration granted 41 orthopedic- and spine-related device clearances in June. 1. SMR Resurfacing Shoulder System from Lima Corp.
2. Synthes 3.5 MM VA-LCP Proximal Tibia Plate System from Synthes.
3. CrossFix II Meniscal Repair Device from Cayenne Medical.
5. MAKOplasty Total Hip Application, Rio Standard System from MAKO Surgical.
6. SpineVision Lumis Cannulated Polyaxial Pedicle Screw Fixation System from SpineVision.
7. Capsure PS System from Spine Wave.
8. AppianFx Suture Anchor from KFx Medical.
9. Smith & Nephew External Fixation System Instruments from Smith & Nephew.
11. DePuy Delta Xtend Reverse Shoulder from DePuy.
12. Honour Spacer System from Nexxt Spine.
13. Renovis Surgical Hip Joint Prosthesis from Renovis Surgical Technologies.
14. Spineology PEEK Lumbar Interbody Fusion Devices from Spineology.
15. Mini Maxlock Extreme Plating System from OrthoHelix Surgical Designs.
16. Synthes Scout Tack Fixation from Synthes Spine.
17. Expedium Spine System, Viper Spine System, Viper 2 System from DePuy Spine.
18. Revere 4.5 Stabilization System from Globe Medical.
20. Zimmer Trabecular Metal Technology from Zimmer.
21. Audit MicroLQ Spinal Fluid Control from AALTO Scientific.
22. Polaris Spinal System-Ballista Spinal Rods from Biomet Spine.
23. Medyssy LT Cage System from Medyssey.
24. Alpha Orthopaedics AT2 System from Alpha Orthopaedics.
25. Synthes VA LCP Ankle Trauma System from Synthes USA.
26. Synthes Radial Head Prosthesis System from Synthes USA.
27. Linear Porous Coated Hip Stem, Revelation Hip Stem, Foundation Porous Press Fit Stem from Encore Medical.
28. OP Spine System from Orthopediatrics.
29. Blue Mountain Cervical Plate from QualGenix.
30. Ascend Shoulder System from Tornier.
32. BioRaptor from Smith & Nephew.
33. Xia 4.5 Spinal System from Stryker.
34. XtraFix Enternal Fixation System from ExtraOrtho.
35. Enspire Discectomy System from Spine View.
36. LDR Spine SpineTune TL Spinal System form LDR Spine USA.
37. Unify Dynamic Anterior Cervical Plate System from Globe Medical.
38. Range Spinal System from K2M.
39. Vu aPOD Intervertebral Body Fusion Device from Theken Spine.
40. NuVasive Corent Titanium System from NuVasive.
41. Vertex Reconstruction System from Medtronic Sofamor Danek.
More Articles on FDA Clearances:
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in May
33 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in April
38 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March
2. Synthes 3.5 MM VA-LCP Proximal Tibia Plate System from Synthes.
3. CrossFix II Meniscal Repair Device from Cayenne Medical.
5. MAKOplasty Total Hip Application, Rio Standard System from MAKO Surgical.
6. SpineVision Lumis Cannulated Polyaxial Pedicle Screw Fixation System from SpineVision.
7. Capsure PS System from Spine Wave.
8. AppianFx Suture Anchor from KFx Medical.
9. Smith & Nephew External Fixation System Instruments from Smith & Nephew.
11. DePuy Delta Xtend Reverse Shoulder from DePuy.
12. Honour Spacer System from Nexxt Spine.
13. Renovis Surgical Hip Joint Prosthesis from Renovis Surgical Technologies.
14. Spineology PEEK Lumbar Interbody Fusion Devices from Spineology.
15. Mini Maxlock Extreme Plating System from OrthoHelix Surgical Designs.
16. Synthes Scout Tack Fixation from Synthes Spine.
17. Expedium Spine System, Viper Spine System, Viper 2 System from DePuy Spine.
18. Revere 4.5 Stabilization System from Globe Medical.
20. Zimmer Trabecular Metal Technology from Zimmer.
21. Audit MicroLQ Spinal Fluid Control from AALTO Scientific.
22. Polaris Spinal System-Ballista Spinal Rods from Biomet Spine.
23. Medyssy LT Cage System from Medyssey.
24. Alpha Orthopaedics AT2 System from Alpha Orthopaedics.
25. Synthes VA LCP Ankle Trauma System from Synthes USA.
26. Synthes Radial Head Prosthesis System from Synthes USA.
27. Linear Porous Coated Hip Stem, Revelation Hip Stem, Foundation Porous Press Fit Stem from Encore Medical.
28. OP Spine System from Orthopediatrics.
29. Blue Mountain Cervical Plate from QualGenix.
30. Ascend Shoulder System from Tornier.
32. BioRaptor from Smith & Nephew.
33. Xia 4.5 Spinal System from Stryker.
34. XtraFix Enternal Fixation System from ExtraOrtho.
35. Enspire Discectomy System from Spine View.
36. LDR Spine SpineTune TL Spinal System form LDR Spine USA.
37. Unify Dynamic Anterior Cervical Plate System from Globe Medical.
38. Range Spinal System from K2M.
39. Vu aPOD Intervertebral Body Fusion Device from Theken Spine.
40. NuVasive Corent Titanium System from NuVasive.
41. Vertex Reconstruction System from Medtronic Sofamor Danek.
More Articles on FDA Clearances:
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in May
33 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in April
38 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March