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) → OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

# OIY · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

_Orthopedic · 21 CFR 888.3560 · Class 2_

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

## Overview

- **Product Code:** OIY
- **Device Name:** Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- **Regulation:** [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K242665](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K242665.md) | DePuy ATTUNE™ Total Knee System | Depuy Orthopedics, Inc. | Nov 1, 2024 | SESE |
| [K201347](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K201347.md) | DePuy ATTUNE™ Total Knee System | DePuy Orthopaedics, Inc. | Jun 18, 2020 | SESE |
| [K120038](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K120038.md) | A200 KNEE SYSTEM | Renovis Surgical Technologies, LLC | Feb 14, 2013 | SESE |
| [K121727](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K121727.md) | MOVATION KNEE SYSTEM | Encore Medical L.P. | Aug 15, 2012 | SESE |
| [K113756](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K113756.md) | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA | Encore Medical L.P. | Mar 14, 2012 | SESE |
| [K111433](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K111433.md) | DEPUY STTUNE (TM) PS KNEE SYSTEM | DePuy Orthopaedics, Inc. | Aug 30, 2011 | SESE |
| [K103756](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K103756.md) | DEPUY ATTUNE TOTAL KNEE SYSTEM | DePuy Orthopaedics, Inc. | Mar 15, 2011 | SESE |
| [K103223](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K103223.md) | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS | Encore Medical L.P. | Dec 21, 2010 | SESE |
| [K101433](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K101433.md) | DEPUY ATTUNE KNEE SYSTEM | DePuy Orthopaedics, Inc. | Dec 10, 2010 | SESE |
| [K091956](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K091956.md) | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 | Encore Medical L.P. | Sep 28, 2010 | SESE |
| [K100048](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OIY/K100048.md) | E1 ANTIOXIDANT INFUSED TECHNOLOGY | Biomet Manufacturing Corp | Mar 9, 2010 | SESE |

## Top Applicants

- DePuy Orthopaedics, Inc. — 4 clearances
- Encore Medical L.P. — 4 clearances
- Biomet Manufacturing Corp — 1 clearance
- Depuy Orthopedics, Inc. — 1 clearance
- Renovis Surgical Technologies, LLC — 1 clearance

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

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