KMB · Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
Orthopedic · 21 CFR 888.3490 · Class 2
Overview
| Product Code | KMB |
|---|---|
| Device Name | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented |
| Regulation | 21 CFR 888.3490 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial condylar component or components made of ultra-high molecular weight polyethylene with carbon fibers composite and are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
