21 CFR § 874.3495 - Total ossicular replacement prosthesis.

---
identifier: "/us/cfr/t21/s874.3495"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3495 - Total ossicular replacement prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3495"
section_name: "Total ossicular replacement prosthesis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 874.3495 Total ossicular replacement prosthesis.

(a) *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.

(b) *Classification.* Class II.