---
kind: "section"
citation: "21 C.F.R. § 888.3390"
title: "21"
number: "888.3390"
heading: "Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3390"
---

# §888.3390. Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

- (a) **Identification.** A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement ([§ 888.3027](/cfr/21/888.3027.md)) or implanted by impaction.
- (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.
