[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3120]

[Page 498]
 
                        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 an 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]