[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: 21CFR888.3120]

[Page 478]
 
                        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. 888.3120  Ankle joint metal/polymer non-constrained cemented prosthesis.

    (a) Identification. An ankle joint metal/polymer non-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits minimally (less than normal anatomic 
constraints) translation in one or more planes. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a tibial component made of alloys, such as cobalt-chromium-
molybdenum, and a talar component made of ultra-high molecular weight 
polyethylene, 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 ankle 
joint metal/polymer non-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 ankle 
joint metal/polymer non-constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other ankle joint 
metal/polymer non-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]