[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3160]

[Page 479]
 
                        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. 888.3160  Elbow joint metal/polymer semi-constrained cemented prosthesis.

    (a) Identification. An elbow joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
elbow 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 
consist of a humeral resurfacing component made of alloys, such as 
cobalt-chromium-molybdenum, and a radial resurfacing component made of 
ultra-high molecular weight polyethylene. This generic type of device is 
limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (b) Classification. Class II.