KXC · Prosthesis, Ankle, Cemented, Non-Constrained
Orthopedic · 21 CFR 888.3120 · Class 3
Overview
| Product Code | KXC |
|---|---|
| Device Name | Prosthesis, Ankle, Cemented, Non-Constrained |
| Regulation | 21 CFR 888.3120 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An ankle joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace an ankle 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 tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
