---
kind: "section"
citation: "21 C.F.R. § 888.3040"
title: "21"
number: "888.3040"
heading: "Smooth or threaded metallic bone fixation fastener."
url: "https://uscodex.org/cfr/21/888.3040"
---

# §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.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.