Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3450](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3450) → LBM — Porous Polyethylene Ossicular Replacement

# LBM · Porous Polyethylene Ossicular Replacement

_Ear, Nose, Throat · 21 CFR 874.3450 · Class 2_

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

## Overview

- **Product Code:** LBM
- **Device Name:** Porous Polyethylene Ossicular Replacement
- **Regulation:** [21 CFR 874.3450](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3450)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823442](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LBM/K823442.md) | FISCH MODIFIED TOTAL OSSICULAR PROSTHES | Treace Medical, Inc. | Dec 3, 1982 | SESE |
| [K823441](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LBM/K823441.md) | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | Treace Medical, Inc. | Dec 3, 1982 | SESE |

## Top Applicants

- Treace Medical, Inc. — 2 clearances

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

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