[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: 21CFR888.3490]

[Page 475]
 
                        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. 888.3490  Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/composite non-
constrained cemented prosthesis is a device intended to be implanted to 
replace part of a knee 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 femoral condylar resurfacing component or 
components made of alloys, such as cobalt-chromium-molybdenum, and a 
tibial condylar component or components made of ultra-high molecular 
weight polyethylene with carbon fibers composite and are intended for 
use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.