The Food and Drug Administration granted 43 orthopedic- and spine-related devices 510(k) clearance in October, according to an FDA report.
1. Reverse Shoulder Prosthesis MonoBlock Hemi Adapter from Encore Medical.
2. Sovereign Spinal System from Medtronic.
3. Zimmer Periarticular Screws from Zimmer.
4. Exeter X3 Rimfit Acetabular Cup from Stryker.
5. Range Spinal System (Mesa and Denali) from K2M.
6. OrthoLoc Bone Screws from Wright Medical Technology.
7. Osteomed Hand Fusion System from Osteomed.
8. Mectacer Biolox Delta Femoral Heads from Medacta USA.
9. Concorde Bullet Spinal System from Johnson & Johnson.
10. Aequalis Ascend Modular Reverse Shoulder System from Tornier.
11. Apex Kirschner Wires and Steinmann Pins from Apex Tools & Orthopedics.
12. Smith & Nephew Cannulated Screws and Washers from Smith & Nephew.
13. SFC Vertebral Body Replacement from Konigsee Implantate.
14. Cornerstone PSR Cervical Fusion System from Medtronic Sofamor Danek.
15. MTF New Bone Void Filler from Musculoskeletal Transplant Foundation.
16. Zimmer Patient Specific Instruments Planner Model 2.5 from Materialise.
17. Polarcup Dual Mobility System from Smith & Nephew.
18. Gladiator Hip Stem from Wright Medical Technology.
19. NovaBone Putty Bioactive Synthetic Bone Graft from NovaBone.
20. GS Medical AnyPlus Peek Lumbar Cages from GS Medical.
21. Zyston Straight Spacer System from Biomet Spine.
22. Everyway Low Back Pain Relief System from Everyway Medical Instruments.
23. SmartLoc Spinal Fixation System from A-Spine Asia.
24. Apclo Pedicle Screw Systems from Atlas Spine.
25. Dash Hip from BrainLab.
26. Tiger Headless Cannulated Screws from Trilliant Surgical.
27. XtraFix External Fixation Systems from ExtraOrtho.
28. Synthes XRL from Synthes Spine.
29. Enspire Debrider System from Spine View.
30. CD Horizon Spinal System from Medtronic.
31. Venus Interbody Fixation System—Venus PLIF/TLIF, ALIF Peek Cage from L&K Biomed.
32. Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left and Right; Anterior Clavicle Plate from Advanced Orthopaedic Solutions.
33. ProSeries BioImplants—ProAnkle/ProCuff from Synovis Orthopedic and Woundcare.
34. Healix Knotless Anchor from DePuy Mitek.
35. Skaffold CIS from Skeletal Kinetics.
36. Vusion OS from Ortho Development.
37. Expedium Spine System from Johnson & Johnson.
38. BoneBac T-PLIF Intervertebral Body Fusion Device System from Thompson MIS.
39. NCB Periprosthetic Femur Polyaxial Locking Plate System from Zimmer.
40. Synthes Sternal Fixation System from Synthes.
41. Invizia Anterior Cervical Plate System from Zimmer Spine.
42. Mahe Perfect Spine-Pedicle Screw System from Mahe Medical.
43. Distal Volar Radius Plating System from Medos International Sarl.
Related Articles on FDA Clearances:
25 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in September
42 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August
46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August
1. Reverse Shoulder Prosthesis MonoBlock Hemi Adapter from Encore Medical.
2. Sovereign Spinal System from Medtronic.
3. Zimmer Periarticular Screws from Zimmer.
4. Exeter X3 Rimfit Acetabular Cup from Stryker.
5. Range Spinal System (Mesa and Denali) from K2M.
6. OrthoLoc Bone Screws from Wright Medical Technology.
7. Osteomed Hand Fusion System from Osteomed.
8. Mectacer Biolox Delta Femoral Heads from Medacta USA.
9. Concorde Bullet Spinal System from Johnson & Johnson.
10. Aequalis Ascend Modular Reverse Shoulder System from Tornier.
11. Apex Kirschner Wires and Steinmann Pins from Apex Tools & Orthopedics.
12. Smith & Nephew Cannulated Screws and Washers from Smith & Nephew.
13. SFC Vertebral Body Replacement from Konigsee Implantate.
14. Cornerstone PSR Cervical Fusion System from Medtronic Sofamor Danek.
15. MTF New Bone Void Filler from Musculoskeletal Transplant Foundation.
16. Zimmer Patient Specific Instruments Planner Model 2.5 from Materialise.
17. Polarcup Dual Mobility System from Smith & Nephew.
18. Gladiator Hip Stem from Wright Medical Technology.
19. NovaBone Putty Bioactive Synthetic Bone Graft from NovaBone.
20. GS Medical AnyPlus Peek Lumbar Cages from GS Medical.
21. Zyston Straight Spacer System from Biomet Spine.
22. Everyway Low Back Pain Relief System from Everyway Medical Instruments.
23. SmartLoc Spinal Fixation System from A-Spine Asia.
24. Apclo Pedicle Screw Systems from Atlas Spine.
25. Dash Hip from BrainLab.
26. Tiger Headless Cannulated Screws from Trilliant Surgical.
27. XtraFix External Fixation Systems from ExtraOrtho.
28. Synthes XRL from Synthes Spine.
29. Enspire Debrider System from Spine View.
30. CD Horizon Spinal System from Medtronic.
31. Venus Interbody Fixation System—Venus PLIF/TLIF, ALIF Peek Cage from L&K Biomed.
32. Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left and Right; Anterior Clavicle Plate from Advanced Orthopaedic Solutions.
33. ProSeries BioImplants—ProAnkle/ProCuff from Synovis Orthopedic and Woundcare.
34. Healix Knotless Anchor from DePuy Mitek.
35. Skaffold CIS from Skeletal Kinetics.
36. Vusion OS from Ortho Development.
37. Expedium Spine System from Johnson & Johnson.
38. BoneBac T-PLIF Intervertebral Body Fusion Device System from Thompson MIS.
39. NCB Periprosthetic Femur Polyaxial Locking Plate System from Zimmer.
40. Synthes Sternal Fixation System from Synthes.
41. Invizia Anterior Cervical Plate System from Zimmer Spine.
42. Mahe Perfect Spine-Pedicle Screw System from Mahe Medical.
43. Distal Volar Radius Plating System from Medos International Sarl.
Related Articles on FDA Clearances:
25 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in September
42 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August
46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August