[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3180]

[Page 499-500]
 
                        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

[[Page 500]]

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]