[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: 21CFR888.3358]

[Page 502-503]
 
                        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. 888.3358  Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis.

    (a) Identification. A hip joint metal/polymer/metal semi-constrained 
porous-coated uncemented prosthesis is a

[[Page 503]]

device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-
chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium 
(Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high 
molecular weight polyethylene articulating bearing surface fixed in a 
metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and 
acetabular shell have a porous coating made of, in the case of Co-Cr-Mo 
substrates, beads of the same alloy, and in the case of Ti-6Al-4V 
substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The 
porous coating has a volume porosity between 30 and 70 percent, an 
average pore size between 100 and 1,000 microns, interconnecting 
porosity, and a porous coating thickness between 500 and 1,500 microns. 
The generic type of device has a design to achieve biological fixation 
to bone without the use of bone cement.
    (b) Classification. Class II.

[58 FR 3228, Jan. 8, 1993]