[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: 21CFR888.3100]

[Page 497-498]
 
                        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. 888.3100  Ankle joint metal/composite semi-constrained cemented prosthesis.

    (a) Identification. An ankle joint metal/composite semi-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits translation and

[[Page 498]]

rotation: in one or more planes via the geometry of its articulating 
surfaces. It has no linkage across-the-joint. This generic type of 
device includes prostheses that consist of a talar resurfacing component 
made of alloys, such as cobalt-chromium-molybdenum, and a tibial 
resurfacing component fabricated from ultra-high molecular weight 
polyethylene with carbon fibers composite, and is limited to those 
prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.