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) → LBP — Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material

# LBP · Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material

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

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

## Overview

- **Product Code:** LBP
- **Device Name:** Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
- **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 (0 of 0)

_No cleared devices on record._

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

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