eCFR.io
Daily eCFR

§ 874.3495 Total ossicular replacement prosthesis.

21 CFR 874.3495

Citation21 CFR 874.3495
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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.