[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3353]

[Page 464]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 888.3353  Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    (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, A1203) 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]