[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: 21CFR888.3370]

[Page 483]
 
                        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. 888.3370  Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    (a) Identification. A hip joint (hemi-hip) acetabular metal cemented 
prosthesis is a device intended to be implanted to replace a portion of 
the hip joint. This generic type of device includes prostheses that have 
an acetabular component made of alloys, such as cobalt-chromium-
molybdenum. This generic type of device is limited to those prostheses 
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 
(hemi-hip) acetabular metal 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 (hemi-hip) 
acetabular metal cemented prosthesis that was in commercial distribution 
before May 28, 1976. Any other hip joint metal (hemi-hip) acetabular 
metal 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]