[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3160]

[Page 460-461]
 
                        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

[[Page 461]]

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.