[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: 21CFR888.3360]

[Page 483]
 
                        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. 888.3360  Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) metallic cemented 
or uncemented prosthesis is a device intended to be implanted to replace 
a portion of the hip joint. This generic type of device includes 
prostheses that have a femoral component made of alloys, such as cobalt-
chromium-molybdenum. This generic type of device includes designs which 
are intended to be fixed to the bone with bone cement (Sec. 888.3027) as 
well as designs which have large window-like holes in the stem of the 
device and which are intended for use without bone cement. However, in 
these latter designs, fixation of the device is not achieved by means of 
bone ingrowth.
    (b) Classification. Class II.