---
kind: "section"
citation: "21 C.F.R. § 888.3320"
title: "21"
number: "888.3320"
heading: "Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis."
url: "https://uscodex.org/cfr/21/888.3320"
---

# §888.3320. Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

- (a) **Identification.** A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement ([§ 888.3027](/cfr/21/888.3027.md)).
- (b) **Classification.** Class III.
- (c) **Date PMA or notice of completion of PDP is required.** A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

## Notes

### Amendments

[52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Feb. 18, 2016]

### 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

[52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Feb. 18, 2016]