Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3120](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3120) → KXC — Prosthesis, Ankle, Cemented, Non-Constrained

# KXC · Prosthesis, Ankle, Cemented, Non-Constrained

_Orthopedic · 21 CFR 888.3120 · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/KXC

## Overview

- **Product Code:** KXC
- **Device Name:** Prosthesis, Ankle, Cemented, Non-Constrained
- **Regulation:** [21 CFR 888.3120](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3120)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **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._

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**Source:** [https://fda.innolitics.com/productcode/KXC](https://fda.innolitics.com/productcode/KXC)

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