[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: 21CFR888.3380]

[Page 483-484]
 
                        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. 888.3380  Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) trunnion-bearing 
metal/polyacetal cemented 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 consist of a metallic stem made of 
alloys, such as cobalt-chromium-molybdenum, with an integrated 
cylindrical trunnion bearing at the upper end of the stem that fits into 
a recess in the head of the device. The head of the device is made of 
polyacetal (polyoxymethylene) and it is covered by a metallic alloy, 
such as cobalt-chromium-molybdenum. The trunnion bearing allows the head 
of the device to rotate on its stem. The prosthesis is intended for use 
with bone cement (Sec. 888.3027).
    (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 
femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented 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 femoral (hemi-hip)

[[Page 484]]

trunnion-bearing metal/polyacetal cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other hip joint femoral 
(hemi-hip) trunnion-bearing metal/polyacetal cemented 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]