[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: 21CFR888.3310]

[Page 481]
 
                        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. 888.3310  Hip joint metal/polymer constrained cemented or uncemented prosthesis.

    (a) Identification. A hip joint metal/polymer constrained cemented 
or uncemented prosthesis is a device intended to be implanted to replace 
a hip joint. The device prevents dislocation in more than one anatomic 
plane and has components that are linked together. This generic type of 
device includes prostheses that have a femoral component made of alloys, 
such as cobalt-chromium-molybdenum, and an acetabular component made of 
ultra-high-molecular-weight polyethylene with or without a metal shell, 
made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. 
This generic type of device is intended for use with or without bone 
cement (Sec. 888.3027).
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or 
Uncemented Prosthesis.''

[67 FR 21173, Apr. 30, 2002]