21 CFR 888.3490 — Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3490
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KMB | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented | 2 | 0 | Implant |
| KTX | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented | 2 | 0 | Implant |
