21 CFR § 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

---
identifier: "/us/cfr/t21/s874.3540"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3540 - Prosthesis modification instrument for ossicular replacement surgery."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3540"
section_name: "Prosthesis modification instrument for ossicular replacement surgery."
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"
---


# 874.3540 Prosthesis modification instrument for ossicular replacement surgery.

(a) *Identification.* A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoam 
<sup>TM</sup> punch; wire cutting scissors; and ossicular finger vise.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000; 90 FR 55985, Dec. 4, 2025]