Part 888 Subpart D—Prosthetic Devices
FDA submissions for Part 888 Subpart D—Prosthetic Devices in the Orthopedic (OR) review panel, including product codes and regulations.
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 | 37 |
| NVC | Bone, Heterograft | 888.3015 | 3 | 0 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 888.3020 | 2 | 525 |
| 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 | 1309 |
| 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 | 220 |
| 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 | 1058 |
| 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 | 594 |
| 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 | 491 |
| 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 | 2 |
| 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 | 30 |
| 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 | 666 |
| 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 | 899 |
| 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 | 896 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 888.3080 | 2 | 349 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 888.3080 | 2 | 200 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 888.3080 | 2 | 160 |
| 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 | 563 |
| 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 | 530 |
| 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 | 5 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 888.3358 | 2 | 560 |
| 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 | 107 |
| 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 | 911 |
| 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 | 12 |
| 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 | 143 |
| 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 | 201 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 888.3660 | 2 | 19 |
| 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 |
