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

---
identifier: "/us/cfr/t21/s888.3390"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3390"
section_name: "Hip joint femoral (hemi-hip) metal/polymer 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"
---


# 888.3390 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) or implanted by impaction.

(b) *Classification.* Class II.