[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3350]

[Page 482]
 
                        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. 888.3350  Hip joint metal/polymer semi-constrained cemented prosthesis.

    (a) Identification. A hip joint metal/polymer semi-constrained 
cemented prosthesis is a 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 
have a femoral component made of alloys, such as cobalt-chromium-
molybdenum, and an acetabular resurfacing component made of ultra-high 
molecular weight polyethylene and is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.