[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3200]

[Page 470]
 
                        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. 888.3200  Finger joint metal/metal constrained uncemented prosthesis.

    (a) Identification. A finger joint metal/metal constrained 
uncemented prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal or proximal interphalangeal (finger) joint. The 
device prevents dislocation in more than one anatomic plane and consists 
of two components which are linked together. This generic type of device 
includes prostheses made of alloys, such as cobalt-chromium-molybdenum, 
or protheses made from alloys and ultra-high molecular weight 
polyethylene. This generic type of device is limited to prostheses 
intended for use without 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 finger 
joint metal/metal constrained 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 finger 
joint metal/metal constrained uncemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other finger joint 
metal/metal constrained 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 50709, Sept. 27, 1996]