21 CFR § 874.3450 - Partial ossicular replacement prosthesis.

---
identifier: "/us/cfr/t21/s874.3450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3450 - Partial ossicular replacement prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3450"
section_name: "Partial 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"
---


# 874.3450 Partial ossicular replacement prosthesis.

(a) *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.

(b) *Classification.* Class II.