Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3680](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3680) → KYM — Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

# KYM · Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

_Orthopedic · 21 CFR 888.3680 · Class 3_

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

## Overview

- **Product Code:** KYM
- **Device Name:** Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
- **Regulation:** [21 CFR 888.3680](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3680)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight polyethylene and intended to be implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses 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/KYM](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYM)

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