---
kind: "section"
citation: "21 C.F.R. § 888.3310"
title: "21"
number: "888.3310"
heading: "Hip joint metal/polymer constrained cemented or uncemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3310"
---

# §888.3310. Hip joint metal/polymer constrained cemented or uncemented prosthesis.

- (a) **Identification.** A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement ([§ 888.3027](/cfr/21/888.3027.md)).
- (b) **Classification.** Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

## Notes

### Amendments

[67 FR 21173, Apr. 30, 2002]

### 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.

### Amendments

[67 FR 21173, Apr. 30, 2002]