21 C.F.R. § 888.3353

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Last amended: 2016Year: 2026Length: 153 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.3353 (2026)

(a) Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1 2 0 3 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239, Nov. 22, 1989; 54 FR 51342, Dec. 14, 1989]
21 C.F.R. § 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. | Justis AI