21 CFR 888.3390
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 888.3390, § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91097
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.