KRP · Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
Orthopedic · 21 CFR 888.3550 · Class 3
Overview
| Product Code | KRP |
|---|---|
| Device Name | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal |
| Regulation | 21 CFR 888.3550 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
