21 C.F.R. § 888.3400
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
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.