Part 888 Subpart D—Prosthetic Devices
FDA submissions for Part 888 Subpart D—Prosthetic Devices in the Orthopedic (OR) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 888.3000–888.3810
CFR Part: 888
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| JDT | Cap, Bone | 888.3000 | 1 | 0 |
| JDQ | Cerclage, Fixation | 888.3010 | 2 | 129 |
| NDD | Cerclage, Fixation, Metallic | 888.3010 | 2 | 1 |
| OWI | Bone Fixation Cerclage, Sublaminar | 888.3010 | 2 | 36 |
| NVC | Bone, Heterograft | 888.3015 | 3 | 0 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 888.3020 | 2 | 522 |
| NDE | Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible | 888.3020 | 2 | 0 |
| SAI | Ankle Fusion Cage | 888.3020 | 2 | 2 |
| QAD | Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated | 888.3023 | 2 | 7 |
| HXA | Prosthesis, Tendon, Passive | 888.3025 | 2 | 11 |
| LOD | Bone Cement | 888.3027 | 2 | 79 |
| MBB | Bone Cement, Antibiotic | 888.3027 | 2 | 19 |
| NDN | Cement, Bone, Vertebroplasty | 888.3027 | 2 | 108 |
| NUD | Vertebroplasty Compound, Calcium Based | 888.3027 | 2 | 0 |
| OBL | Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty | 888.3027 | 2 | 1 |
| OBM | Cement, Bone, Vertebroplasty, Pre-Formed, Modular | 888.3027 | 2 | 0 |
| PML | Bone Cement, Posterior Screw Augmentation | 888.3027 | 2 | 18 |
| HRS | Plate, Fixation, Bone | 888.3030 | 2 | 1303 |
| HTN | Washer, Bolt Nut | 888.3030 | 2 | 92 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 888.3030 | 2 | 23 |
| JDP | Condylar Plate Fixation Implant | 888.3030 | 2 | 2 |
| JDR | Staple, Fixation, Bone | 888.3030 | 2 | 231 |
| JDS | Nail, Fixation, Bone | 888.3030 | 2 | 53 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 888.3030 | 2 | 403 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 888.3030 | 2 | 38 |
| KWK | Appliance, Nail/Blade/Plate Combination, Single Component | 888.3030 | 2 | 1 |
| LRN | Wire, Surgical | 888.3030 | 2 | 8 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 888.3030 | 2 | 57 |
| LYT | Fixation Accessory | 888.3030 | 2 | 9 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 888.3030 | 2 | 219 |
| MNU | Staple, Absorbable | 888.3030 | 2 | 4 |
| NDF | Plate, Fixation, Bone, Non-Spinal, Metallic | 888.3030 | 2 | 3 |
| NDG | Washer, Bolt, Nut, Non-Spinal, Metallic | 888.3030 | 2 | 1 |
| NDH | Nail, Fixation, Bone, Metallic | 888.3030 | 2 | 0 |
| NDI | Staple, Fixation, Bone, Metallic | 888.3030 | 2 | 0 |
| NOV | Anchor, Suture, Bone Fixation, Metallic | 888.3030 | 2 | 1 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 888.3030 | 2 | 6 |
| OOL | Electronic Depth Gauge | 888.3030 | 2 | 1 |
| OSN | Software For Diagnosis/Treatment | 888.3030 | 2 | 4 |
| OZI | Internal Hinged Elbow Fixator | 888.3030 | 2 | 3 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 888.3030 | 2 | 27 |
| PLF | Bone Wedge | 888.3030 | 2 | 18 |
| HTY | Pin, Fixation, Smooth | 888.3040 | 2 | 204 |
| HWC | Screw, Fixation, Bone | 888.3040 | 2 | 1054 |
| JDW | Pin, Fixation, Threaded | 888.3040 | 2 | 94 |
| JEC | Component, Traction, Invasive | 888.3040 | 2 | 85 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 888.3040 | 2 | 589 |
| MJW | Prosthesis, Subtalar, Plug, Polymer | 888.3040 | 2 | 2 |
| MRY | Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component | 888.3040 | 2 | 0 |
| NDJ | Screw, Fixation, Bone, Non-Spinal, Metallic | 888.3040 | 2 | 0 |
| NDK | System, External Fixator (With Metallic Invasive Components) | 888.3040 | 2 | 3 |
| NDL | Pin, Fixation, Smooth, Metallic | 888.3040 | 2 | 2 |
| NDM | Pin, Fixation, Threaded, Metallic | 888.3040 | 2 | 1 |
| NJA | Accessory, System, External Fixator, Containing Antimicrobial Agent | 888.3040 | 2 | 0 |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | 888.3040 | 2 | 0 |
| OUR | Sacroiliac Joint Fixation | 888.3040 | 2 | 131 |
| OVZ | Pin, Fixation, Resorbable, Hard Tissue | 888.3040 | 2 | 3 |
| PPQ | Transtibial Anterior Cruciate Ligament Kit | 888.3040 | 2 | 0 |
| QSR | Sacroiliac Screw Placement Guide | 888.3040 | 2 | 1 |
| SCY | Sacroiliac Joint Guidewire Placement Device | 888.3040 | 2 | 1 |
| QJD | Absorbable Metallic Bone Fixation Fastener | 888.3041 | 2 | 1 |
| QAC | Screw Sleeve Bone Fixation Device | 888.3043 | 2 | 1 |
| QVI | Screw Sleeve Bone Fixation Device, Spine | 888.3043 | 2 | 2 |
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 888.3044 | 2 | 3 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 888.3045 | 2 | 31 |
| MQV | Filler, Bone Void, Calcium Compound | 888.3045 | 2 | 489 |
| OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | 888.3045 | 2 | 2 |
| QRR | Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside | 888.3046 | 2 | 2 |
| QVL | Absorbable Gel For Intraoperative Use In Spine Surgery | 888.3047 | 2 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 888.3050 | 2 | 430 |
| LYP | Accessories, Fixation, Spinal Interlaminal | 888.3050 | 2 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 888.3050 | 2 | 29 |
| PEK | Spinous Process Plate | 888.3050 | 2 | 48 |
| JDN | Implant, Fixation Device, Spinal | 888.3060 | 2 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 888.3060 | 2 | 663 |
| MQP | Spinal Vertebral Body Replacement Device | 888.3060 | 2 | 277 |
| OJB | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | 888.3060 | 2 | 3 |
| OJM | Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh | 888.3060 | 2 | 0 |
| PHQ | Anterior Staple As Supplemental Fixation For Fusion | 888.3060 | 2 | 2 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 888.3060 | 2 | 18 |
| MDI | Prosthesis, Rib Replacement | 888.3070 | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 888.3070 | 2 | 309 |
| MNI | Orthosis, Spinal Pedicle Fixation | 888.3070 | 2 | 303 |
| NKB | Thoracolumbosacral Pedicle Screw System | 888.3070 | 2 | 892 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 888.3070 | 2 | 22 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 888.3070 | 2 | 19 |
| PGM | Growing Rod System | 888.3070 | 2 | 14 |
| PGN | Growing Rod System- Magnetic Actuation | 888.3070 | 2 | 9 |
| PQC | Pedicle Screw Placement Guide | 888.3070 | 2 | 8 |
| QZY | Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating | 888.3071 | 2 | 1 |
| NKG | Posterior Cervical Screw System | 888.3075 | 2 | 117 |
| QSD | Posterior Cervical Screw Placement Guide | 888.3075 | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 888.3080 | 2 | 890 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 888.3080 | 2 | 346 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 888.3080 | 2 | 198 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 888.3080 | 2 | 158 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | 888.3080 | 2 | 3 |
| OQB | Intervertebral Body Graft Containment Device | 888.3085 | 2 | 4 |
| QFP | Intraoperative Orthopedic Strain Sensor | 888.3090 | 2 | 1 |
| KMD | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite | 888.3100 | 2 | 0 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 888.3110 | 2 | 67 |
| OYK | Ankle Arthroplasty Implantation System | 888.3110 | 2 | 7 |
| KXC | Prosthesis, Ankle, Cemented, Non-Constrained | 888.3120 | 3 | 0 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 888.3150 | 2 | 29 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 888.3160 | 2 | 27 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 888.3170 | 2 | 33 |
| KWJ | Prosthesis, Elbow, Hemi-, Humeral, Metal | 888.3180 | 3 | 0 |
| KWE | Prosthesis, Finger, Constrained, Metal, Uncemented | 888.3200 | 3 | 0 |
| LBC | Prosthesis, Finger, Constrained, Metal, Cemented | 888.3210 | 3 | 0 |
| KWG | Prosthesis, Finger, Constrained, Metal/Polymer | 888.3220 | 3 | 1 |
| KWF | Prosthesis, Finger, Polymer | 888.3230 | 2 | 0 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 888.3230 | 2 | 14 |
| KXD | Prosthesis, Hip, Constrained, Metal | 888.3300 | 3 | 0 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 888.3310 | 2 | 36 |
| PBI | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | 888.3310 | 2 | 2 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 888.3320 | 3 | 45 |
| LTO | Spacer, Cement | 888.3320 | 3 | 0 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 888.3330 | 3 | 114 |
| KMC | Prosthesis, Hip, Semi-Constrained, Composite/Metal | 888.3340 | 2 | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 888.3350 | 2 | 562 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | 888.3350 | 2 | 0 |
| PLW | Acetabular Cup Orientation System | 888.3350 | 2 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 888.3353 | 2 | 529 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | 888.3353 | 2 | 4 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 888.3353 | 2 | 159 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 888.3353 | 2 | 4 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 888.3358 | 2 | 559 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 888.3358 | 2 | 13 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 888.3358 | 2 | 20 |
| JDD | Prosthesis, Upper Femoral | 888.3360 | 2 | 0 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 888.3360 | 2 | 59 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 888.3360 | 2 | 106 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 888.3360 | 2 | 81 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | 888.3360 | 2 | 8 |
| KWB | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal | 888.3370 | 3 | 0 |
| JDH | Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal | 888.3380 | 3 | 0 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 888.3390 | 2 | 99 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 888.3400 | 2 | 23 |
| KXB | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer | 888.3410 | 3 | 0 |
| OCG | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented | 888.3410 | 3 | 0 |
| HRZ | Prosthesis, Knee, Hinged (Metal-Metal) | 888.3480 | 3 | 0 |
| KRN | Metal Cemented Constrained Femorotibial Knee Prosthesis | 888.3480 | 3 | 0 |
| KMB | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented | 888.3490 | 2 | 0 |
| KTX | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented | 888.3490 | 2 | 0 |
| KYK | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite | 888.3500 | 2 | 3 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 888.3510 | 2 | 86 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 888.3520 | 2 | 114 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 888.3530 | 2 | 92 |
| LGE | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | 888.3530 | 2 | 2 |
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | 888.3535 | 2 | 5 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 888.3540 | 2 | 27 |
| KRP | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal | 888.3550 | 3 | 0 |
| KRQ | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | 888.3550 | 2 | 0 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 888.3560 | 2 | 910 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | 888.3560 | 2 | 14 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 888.3560 | 2 | 12 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 888.3560 | 2 | 11 |
| OOG | Knee Arthroplasty Implantation System | 888.3560 | 2 | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 888.3565 | 2 | 142 |
| HSA | Prosthesis, Knee, Hemi-, Femoral | 888.3570 | 3 | 0 |
| KRS | Prosthesis, Knee, Hemi-, Femoral (Uncemented) | 888.3570 | 3 | 0 |
| HTG | Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented | 888.3580 | 2 | 2 |
| HSH | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) | 888.3590 | 2 | 5 |
| QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 888.3600 | 2 | 4 |
| QVV | Medial Knee Implanted Shock Absorber | 888.3610 | 2 | 1 |
| QPQ | Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed | 888.3630 | 2 | 1 |
| KWR | Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented | 888.3640 | 3 | 0 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 888.3650 | 2 | 71 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 888.3660 | 2 | 190 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | 888.3660 | 2 | 1 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 888.3660 | 2 | 200 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 888.3660 | 2 | 18 |
| QHE | Shoulder Arthroplasty Implantation System | 888.3660 | 2 | 24 |
| QHQ | Total Shoulder Arthroplasty System | 888.3660 | 2 | 1 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 888.3670 | 2 | 37 |
| KYM | Metallic Cemented Glenoid Hemi-Shoulder Prosthesis | 888.3680 | 3 | 0 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 888.3690 | 2 | 71 |
| QKW | Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | 888.3695 | 2 | 1 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 888.3720 | 2 | 21 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 888.3730 | 2 | 46 |
| KWN | Prosthesis, Wrist, Carpal Lunate | 888.3750 | 2 | 5 |
| KWO | Prosthesis, Wrist, Carpal Scaphoid | 888.3760 | 2 | 1 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 888.3770 | 2 | 26 |
| KIG | Prosthesis, Wrist, Constrained, Polymer | 888.3780 | 2 | 0 |
| KYN | Prosthesis, Wrist, Constrained, Metal | 888.3790 | 3 | 0 |
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | 888.3800 | 2 | 3 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 888.3800 | 2 | 17 |
| KWM | Prosthesis, Wrist, Semi-Constrained | 888.3800 | 2 | 6 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 888.3810 | 2 | 16 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | Apr 17, 2026 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | Apr 17, 2026 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | Apr 16, 2026 |
| K253260 | ORIO-3D Cage System | SpineCraft | Apr 16, 2026 |
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | Apr 15, 2026 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Apr 15, 2026 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | Apr 15, 2026 |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | Apr 14, 2026 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | Apr 13, 2026 |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | Apr 13, 2026 |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | Apr 13, 2026 |
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | Apr 13, 2026 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | Apr 10, 2026 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | Apr 10, 2026 |
| K260477 | CATAMARAN SI Joint Fusion System | Tenon Medical | Apr 8, 2026 |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | Apr 6, 2026 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Apr 3, 2026 |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | Apr 3, 2026 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | Apr 3, 2026 |
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | Apr 3, 2026 |
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Apr 2, 2026 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | Apr 1, 2026 |
| K242303 | MOD-C | Orthomod, LLC | Apr 1, 2026 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | Mar 30, 2026 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | Mar 30, 2026 |
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | Mar 27, 2026 |
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | Mar 27, 2026 |
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | Mar 27, 2026 |
| K252064 | MedCAD® AccuStride System | Medcad | Mar 27, 2026 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | Mar 25, 2026 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | Mar 25, 2026 |
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | Mar 25, 2026 |
| K252432 | Flex-Z Cervical Cage | Spinepoint, LLC | Mar 25, 2026 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | Mar 24, 2026 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | Mar 23, 2026 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | Mar 23, 2026 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | Mar 20, 2026 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | Mar 20, 2026 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | Mar 19, 2026 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | Mar 18, 2026 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | Mar 18, 2026 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | Mar 17, 2026 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | Mar 17, 2026 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | Mar 17, 2026 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | Mar 16, 2026 |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | Mar 16, 2026 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | Mar 16, 2026 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | Mar 12, 2026 |
| K252401 | implaFit® short stems | Implantcast GmbH | Mar 12, 2026 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | Mar 12, 2026 |
| K253906 | Xpert Hand | Newclip Technics | Mar 11, 2026 |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | Mar 11, 2026 |
| K253624 | INHANCE Reverse Shoulder System | Depuy Ireland UC | Mar 11, 2026 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | Mar 10, 2026 |
| K260405 | FiberTape Button | Arthrex, Inc. | Mar 9, 2026 |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | Mar 9, 2026 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | Mar 9, 2026 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | Mar 6, 2026 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | Mar 6, 2026 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Mar 5, 2026 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | Mar 5, 2026 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | Mar 4, 2026 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | Mar 4, 2026 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | Mar 4, 2026 |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | Mar 3, 2026 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | Mar 3, 2026 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | Mar 2, 2026 |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | Mar 2, 2026 |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | Feb 27, 2026 |
| K253695 | LigaMend | Riverpoint Medical, LLC | Feb 27, 2026 |
| K254182 | Aster | Osteonic Co., Ltd. | Feb 26, 2026 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | Feb 26, 2026 |
| K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | Feb 26, 2026 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | Feb 26, 2026 |
| K252166 | RIB LINK Fixation System | Globus Medical, Inc. | Feb 26, 2026 |
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | Feb 25, 2026 |
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | Feb 25, 2026 |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | Feb 24, 2026 |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | Feb 24, 2026 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | Feb 23, 2026 |
| K253169 | Duet Spinal Fixation System | Box Spine, LLC | Feb 23, 2026 |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | Feb 20, 2026 |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | Feb 20, 2026 |
| K252733 | ATLAS Expandable Osteotomy Wedge System | MiRus, LLC | Feb 19, 2026 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 18, 2026 |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | Feb 17, 2026 |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | Feb 17, 2026 |
| K254105 | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | Feb 13, 2026 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | Feb 12, 2026 |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | Feb 12, 2026 |
| K253488 | iFuse INTRA Ti Implant System | SI-BONE, Inc. | Feb 11, 2026 |
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | Feb 10, 2026 |
| K253545 | Vulcan Spinal System | K2m, Inc. | Feb 10, 2026 |
| K260104 | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | Feb 4, 2026 |
| K260038 | E3D-C Interbody System | Evolution Spine | Feb 4, 2026 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | Feb 4, 2026 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | Feb 4, 2026 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | Feb 3, 2026 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | Feb 3, 2026 |
| K253763 | Y-Knotless Flex Anchors | Conmed Corporation | Jan 29, 2026 |
