Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3490](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3490) → KMB — Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented

# KMB · Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented

_Orthopedic · 21 CFR 888.3490 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KMB

## Overview

- **Product Code:** KMB
- **Device Name:** Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
- **Regulation:** [21 CFR 888.3490](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3490)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KMB](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KMB)

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