21 CFR § 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

---
identifier: "/us/cfr/t21/s888.3310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3310"
section_name: "Hip joint metal/polymer constrained cemented or uncemented 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"
---


# 888.3310 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).

(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.”

[67 FR 21173, Apr. 30, 2002]