§ 888.3390. Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
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/us/cfr/t21/s§ 888.3390·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.