[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: 21CFR888.3358]

[Page 482-483]
 
                        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. 888.3358  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 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

[[Page 483]]

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]