21 CFR § 888.3040 - Smooth or threaded metallic bone fixation fastener.
---
identifier: "/us/cfr/t21/s888.3040"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3040 - Smooth or threaded metallic bone fixation fastener."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3040"
section_name: "Smooth or threaded metallic bone fixation fastener."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC 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: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---
# 888.3040 Smooth or threaded metallic bone fixation fastener.
(a) *Identification.* A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
(b) *Classification.* Class II.