[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: 21CFR888.3110]

[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. 888.3110  Ankle joint metal/polymer semi-constrained 
cemented prosthesis.

    (a) Identification. An ankle joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits translation and rotation in one or more 
planes via the geometry of its articulating surfaces and has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a talar resurfacing component made of alloys, such as cobalt-
chromium-molybdenum, and a tibial resurfacing 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 II.