KTX · Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
Orthopedic · 21 CFR 888.3490 · Class 2
Overview
| Product Code | KTX |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite 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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
