Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3495](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3495) → LBN — Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

# LBN · Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

_Ear, Nose, Throat · 21 CFR 874.3495 · Class 2_

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

## Overview

- **Product Code:** LBN
- **Device Name:** Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
- **Regulation:** [21 CFR 874.3495](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3495)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K822367](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LBN/K822367.md) | TOTAL | Treace Medical, Inc. | Sep 7, 1982 | SESE |

## Top Applicants

- Treace Medical, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com