[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: 21CFR888.3210]

[Page 461-462]
 
                        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. 888.3210  Finger joint metal/metal constrained cemented prosthesis.

    (a) Identification. A finger joint metal/metal constrained cemented 
prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal (finger) joint. This device prevents dislocation in 
more than one anatomic plane and has components which are linked 
together. This generic type of device includes prostheses that are made 
of alloys,

[[Page 462]]

such as cobalt-chromium-molybdenum, and 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 finger 
joint metal/metal constrained 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 finger joint metal/
metal constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any other finger joint metal/metal 
constrained 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 50709, Sept. 27, 1996]