21 CFR § 888.3360 Orthopedic Devices

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

(b) Classification. Class II.

← § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.§ 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis. →