[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3500]

[Page 475-476]
 
                        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. 888.3500  Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/composite semi-
constrained cemented prosthesis is a two-part device intended to be 
implanted to replace part of a knee joint. The device limits translation 
and 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 have a femoral component made of alloys, 
such as cobalt-chromium-molybdenum, and a tibial component with the 
articulating surfaces made of ultra-high molecular weight

[[Page 476]]

polyethylene with carbon-fibers composite and is limited to those 
prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.