Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3550](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3550) → KRP — Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal

# KRP · Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal

_Orthopedic · 21 CFR 888.3550 · Class 3_

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

## Overview

- **Product Code:** KRP
- **Device Name:** Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
- **Regulation:** [21 CFR 888.3550](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3550)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are 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/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KRP](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KRP)

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