[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: 21CFR888.3180]

[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. 888.3180  Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    (a) Identification. An elbow joint humeral (hemi-elbow) metallic 
uncemented prosthesis is a device intended to be implanted made of 
alloys, such as cobalt-chromium-molybdenum, that is used to replace the 
distal end of the humerus formed by the trochlea humeri and the 
capitulum humeri. The generic type of device is limited to prostheses 
intended for use without bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any elbow 
joint humeral (hemi-elbow) metallic uncemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to an elbow 
joint humeral (hemi-elbow) metallic uncemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other elbow joint 
humeral (hemi-elbow) metallic uncemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]