KMD · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
Orthopedic · 21 CFR 888.3100 · Class 2
Overview
| Product Code | KMD |
|---|---|
| Device Name | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite |
| Regulation | 21 CFR 888.3100 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation: in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component fabricated from ultra-high molecular weight polyethylene with carbon fibers composite, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
