Table 7.
FDA classification of hip prostheses
| FDA device class | FDA-designated product code* | FDA device classification description | FDA regulatory process |
|---|---|---|---|
| Class II hip prostheses | KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 510(k) |
| PBI | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | 510(k) | |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 510(k) | |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 510(k) | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 510(k) | |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | 510(k) | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 510(k) | |
| KMC | Prosthesis, Hip, Semi-Constrained, Composite/Metal | 510(k) | |
| OQI | Prosthesis, Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 510(k) | |
| OQH | Prosthesis, Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | 510(k) | |
| OQG | Prosthesis, Hip, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 510(k) | |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | 510(k) | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 510(k) | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 510(k) | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 510(k) | |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 510(k) | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | 510(k) | |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 510(k) | |
| Class III hip prostheses | KXD | Prosthesis, Hip, Constrained, Metal | PMA |
| KWB | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal | PMA | |
| KXB | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer | PMA | |
| OCG | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented | PMA | |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Exemption - 510(k) | |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Exemption - 510(k) | |
| OVO | Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation | PMA | |
| LPF | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | PMA | |
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | PMA | |
| NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | PMA |
* FDA-designated product codes are three-character unique identifiers used by the FDA to classify devices in unique product categories.