21 C.F.R. § 888.3400

Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

Last amended: 2016Year: 2026Length: 48 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.3400 (2026)

(a) Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum. (b) Classification. Class II.
21 C.F.R. § 888.3400: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. | Justis AI