[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: 21CFR888.3310]

[Page 463]
 
                        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. This generic type of device is 
intended for use with or without bone cement (Sec. 888.3027). This 
device is not intended for biological fixation.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any hip joint 
metal/polymer constrained cemented or uncemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a hip 
joint metal/polymer constrained cemented or uncemented prosthesis that 
was in commercial distribution before May 28, 1976. Any other hip joint 
metal/polymer constrained cemented or uncemented prosthesis shall have 
an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]