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

---
identifier: "/us/cfr/t21/s888.3320"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3320"
section_name: "Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis."
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"
---


# 888.3320 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).

(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.

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