[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3340]

[Page 472]
 
                        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. 888.3340  Hip joint metal/composite semi-constrained cemented prosthesis.

    (a) Identification. A hip joint metal/composite semi-constrained 
cemented prosthesis is a two-part device intended to be implanted to 
replace a hip joint. The device limits translation and rotation in one 
or more planes via the geometry of its articulating surfaces. It has no 
linkage across-the-joint. This generic type of device includes 
prostheses that consist of a femoral component made of alloys, such as 
cobalt-chromium-molybdenum, and an acetabular component made of ultra-
high molecular weight polyethylene with carbon fibers composite. Both 
components are intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.

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