Panels › Orthopedic
Orthopedic devices
242 product codes reviewed by the Orthopedic panel. 17,143 510(k) clearances and 7,855 recalls in the FDA data, 79% of those recalls name a 510(k).
437510(k)s in 12 months
190recalls in 12 months
6,173recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 64 | 20 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 20 | 19 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 34 | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 33 | 0 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 | 28 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 2 | 18 | 12 |
| HWC | Screw, Fixation, Bone | 2 | 22 | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 21 | 5 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 24 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 15 | 7 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 9 | 11 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 15 | 0 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 11 | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 5 | 9 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 9 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 11 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 9 | 2 |
| HRX | Arthroscope | 2 | 10 | 0 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 5 | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 9 | 0 |
| OUR | Sacroiliac Joint Fixation | 2 | 7 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 3 | 4 |
| LOD | Bone Cement | 2 | 1 | 6 |
| NKG | Posterior Cervical Screw System | 2 | 5 | 0 |
| QHE | Shoulder Arthroplasty Implantation System | 2 | 4 | 1 |
| HTY | Pin, Fixation, Smooth | 2 | 3 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 4 | 0 |
| JDR | Staple, Fixation, Bone | 2 | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 3 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 4 | 0 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 3 | 0 |
| HTN | Washer, Bolt Nut | 2 | 3 | 0 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | 3 | 0 |
| PLF | Bone Wedge | 2 | 1 | 2 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 2 | 3 | 0 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 | 0 |
| JDQ | Cerclage, Fixation | 2 | 2 | 0 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 2 | 2 | 0 |
| MBB | Bone Cement, Antibiotic | 2 | 0 | 2 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 2 | 0 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 1 | 1 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 2 | 0 |
| PEK | Spinous Process Plate | 2 | 2 | 0 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 2 | 2 | 0 |
| PML | Bone Cement, Posterior Screw Augmentation | 2 | 2 | 0 |
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 2 | 1 | 1 |
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 2 | 2 | 0 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 | 0 | 1 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 2 | 1 | 0 |
| JDW | Pin, Fixation, Threaded | 2 | 1 | 0 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 2 | 1 | 0 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 1 | 0 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 2 | 0 | 1 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 2 | 1 | 0 |
| LGE | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | 2 | 0 | 1 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 2 | 1 | 0 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 1 | 0 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 0 | 1 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 1 | 0 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 0 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 1 | 0 |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | 2 | 0 | 1 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 2 | 1 | 0 |
| OQB | Intervertebral Body Graft Containment Device | 2 | 1 | 0 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 2 | 1 | 0 |
| OSN | Software For Diagnosis/Treatment | 2 | 1 | 0 |
| OYK | Ankle Arthroplasty Implantation System | 2 | 0 | 1 |
| PGM | Growing Rod System | 2 | 1 | 0 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 | 1 | 0 |
| PQC | Pedicle Screw Placement Guide | 2 | 1 | 0 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | 2 | 1 | 0 |
| QVL | Absorbable Gel For Intraoperative Use In Spine Surgery | 2 | 1 | 0 |
| SGL | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant | 2 | 1 | 0 |
| SIN | Automated Intraoperative Spinal Rod Bending System | 2 | 1 | 0 |
| SIQ | Intra-Articular Orthopedic Stereotaxic Navigation Instrument | 2 | 1 | 0 |
| SIT | Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System | 2 | 1 | 0 |
| SJA | Injectable For Thermal Treatment Of Musculoskeletal Pain | 2 | 1 | 0 |
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