Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560) → OOG — Knee Arthroplasty Implantation System

# OOG · Knee Arthroplasty Implantation System

_Orthopedic · 21 CFR 888.3560 · Class 2_

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

## Overview

- **Product Code:** OOG
- **Device Name:** Knee Arthroplasty Implantation System
- **Regulation:** [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K230850](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OOG/K230850.md) | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | Dec 20, 2023 | SESE |
| [K203421](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OOG/K203421.md) | Triathlon AS-1 | Conformis, Inc. | Apr 19, 2021 | SESE |

## Top Applicants

- Conformis, Inc. — 1 clearance
- Enhatch, Inc. — 1 clearance

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

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