Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3500](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3500) → KYK — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

# KYK · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

_Orthopedic · 21 CFR 888.3500 · Class 2_

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

## Overview

- **Product Code:** KYK
- **Device Name:** Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
- **Regulation:** [21 CFR 888.3500](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3500)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of 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 with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K880826](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK/K880826.md) | MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM | Johnson & Johnson Professionals, Inc. | Mar 14, 1988 | SESE |
| [K871118](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK/K871118.md) | MODIFIED TOWNLEY UNICONDYLAR KNEE | Depuy, Inc. | Apr 6, 1987 | SN |
| [K851341](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK/K851341.md) | SYNATOMIC VARIABLE FIT TIBIAL PLATEAU | Depuy, Inc. | Jul 15, 1985 | SESE |

## Top Applicants

- Depuy, Inc. — 2 clearances
- Johnson & Johnson Professionals, Inc. — 1 clearance

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

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