[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: 21CFR888.3390]

[Page 465]
 
                        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. 888.3390  Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) metal/polymer 
cemented or uncemented prosthesis is a two-part device intended to be 
implanted to replace the head and neck of the femur. This generic type 
of device includes prostheses that have a femoral component made of 
alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular 
component made of an alloy, such as cobalt-chromium-molybdenum, and 
ultra-high molecular weight polyethylene. This generic type of device 
may be fixed to the bone with bone cement (Sec. 888.3027) or implanted 
by impaction.
    (b) Classification. Class II.