The Food and Drug Administration granted 46 orthopedic- and spine-related 510(k) device clearances in July, according to an FDA report.
1. Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segment from Zimmer.
2. Trigen Low Profile Bone Screw from Smith & Nephew.
3. U2 Hip System from United Orthopedic.
4. Total Shoulder System from Shoulder Innovations.
5. NovaBone Macropor SI+ Bioactive Bone Graft from NovaBone.
6. Revolk Fenestrated Screw System from Globe Medical.
7. Plateau Spacer System from Life Spine.
8. Osteowedge Opening Wedge Bone Locking System from Graham Medical Technologies.
9. Viper Systems from Johnson & Johnson.
10. Pro Fixation System from Synovis Orthopedic & Wound Care.
11. OrthoSorb Resorbable Pins from DePuy Orthopaedics.
12. Titan TI Suture Anchor System from ArhtroCare.
13. Ellipse Intramedullary Limb Lengthening System from Ellipse Technologies.
14. VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and MISC Bone Screws, Peri-Loc Ankle Fusion Plates from Smith & Nephew.
15. Solanas Avalon Posterior Fixation System from Alphatec Spine.
16. Apex Knee System, Apex All Poly Tibia from OmniLife Science.
17. Atlas Spine Pedicle Screw System from Atlas Spine.
18. Stryker Patient Specific Polymer Implant from Homedica Osteonics.
19. SMR Shoulder System—CTA Humeral Heads from LimaCorporate.
20. Exactech Gibralt Spinal System from Exactech.
21. Capstone R. Spinal System from Medtronic Sofamor Danek.
22. Staxxsd System from Spine Wave.
23. Reverse Shoulder MonoBlock Prosthesis from Encore Medical.
24. SpeedFix Suture Implant from ArthroCare.
25. Pathway from Custom Spine.
26. Eturn Spinal Implant from Icotec.
27. Genesys Spine Tilock System from Genesys Spine.
28. Explore Radial Head Plating System from Acumed.
29. Coren Total Hip System from CorenTec.
30. DePuy Mitek Milagro Interference Screw from DePuy Mitek.
31. DSC/ALF Spinal System from Sintea Plastek.
32. Comprehensive Proximal Humeral Plating System from Biomet Manufacturing.
33. SImmetry Sacroiliac Joint Fusion System from Zyga Technologies.
34. Rexious Spinal Fixation System from Dio Medical.
35. Maestro Wrist Plating System from Biomet Manufacturing.
36. Venus Cervical Spinal Fixation System from L&K Biomed.
37. Cervical Cage from EiserTech.
38. Gil Anchor from DePuy Mitek.
39. NuVasive Anterior Lumbar Plate System from NuVasive.
40. GSO ACP1 Anterior Lumbar Plate System from Gold Standard Orthopedics.
41. 3.7MM/5.0MM Dynamic Locking Screw from Synthes USA.
42. Apex Spine System from SpineCraft.
43. SMR Shoulder System — Revision Stems from LimaCorporate.
44. Synthes Sternal ZipFix System from Synthes.
45. N-Force Fixation System from Innovision.
46. Opterak Logic CR Tibial Insert, Opterak Logical CR Femoral Component from Exactech.
Read the FDA report on medical device clearances in July.
Related Articles on FDA Clearances:
29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June
35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in May
34 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in April
2. Trigen Low Profile Bone Screw from Smith & Nephew.
3. U2 Hip System from United Orthopedic.
4. Total Shoulder System from Shoulder Innovations.
5. NovaBone Macropor SI+ Bioactive Bone Graft from NovaBone.
6. Revolk Fenestrated Screw System from Globe Medical.
7. Plateau Spacer System from Life Spine.
8. Osteowedge Opening Wedge Bone Locking System from Graham Medical Technologies.
9. Viper Systems from Johnson & Johnson.
10. Pro Fixation System from Synovis Orthopedic & Wound Care.
11. OrthoSorb Resorbable Pins from DePuy Orthopaedics.
12. Titan TI Suture Anchor System from ArhtroCare.
13. Ellipse Intramedullary Limb Lengthening System from Ellipse Technologies.
14. VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and MISC Bone Screws, Peri-Loc Ankle Fusion Plates from Smith & Nephew.
15. Solanas Avalon Posterior Fixation System from Alphatec Spine.
16. Apex Knee System, Apex All Poly Tibia from OmniLife Science.
17. Atlas Spine Pedicle Screw System from Atlas Spine.
18. Stryker Patient Specific Polymer Implant from Homedica Osteonics.
19. SMR Shoulder System—CTA Humeral Heads from LimaCorporate.
20. Exactech Gibralt Spinal System from Exactech.
21. Capstone R. Spinal System from Medtronic Sofamor Danek.
22. Staxxsd System from Spine Wave.
23. Reverse Shoulder MonoBlock Prosthesis from Encore Medical.
24. SpeedFix Suture Implant from ArthroCare.
25. Pathway from Custom Spine.
26. Eturn Spinal Implant from Icotec.
27. Genesys Spine Tilock System from Genesys Spine.
28. Explore Radial Head Plating System from Acumed.
29. Coren Total Hip System from CorenTec.
30. DePuy Mitek Milagro Interference Screw from DePuy Mitek.
31. DSC/ALF Spinal System from Sintea Plastek.
32. Comprehensive Proximal Humeral Plating System from Biomet Manufacturing.
33. SImmetry Sacroiliac Joint Fusion System from Zyga Technologies.
34. Rexious Spinal Fixation System from Dio Medical.
35. Maestro Wrist Plating System from Biomet Manufacturing.
36. Venus Cervical Spinal Fixation System from L&K Biomed.
37. Cervical Cage from EiserTech.
38. Gil Anchor from DePuy Mitek.
39. NuVasive Anterior Lumbar Plate System from NuVasive.
40. GSO ACP1 Anterior Lumbar Plate System from Gold Standard Orthopedics.
41. 3.7MM/5.0MM Dynamic Locking Screw from Synthes USA.
42. Apex Spine System from SpineCraft.
43. SMR Shoulder System — Revision Stems from LimaCorporate.
44. Synthes Sternal ZipFix System from Synthes.
45. N-Force Fixation System from Innovision.
46. Opterak Logic CR Tibial Insert, Opterak Logical CR Femoral Component from Exactech.
Read the FDA report on medical device clearances in July.
Related Articles on FDA Clearances:
29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June
35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in May
34 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in April