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.
Cleared Devices (0)
No cleared devices on record.
