[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: 21CFR888.3410]

[Page 504]
 
                        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. 888.3410  Hip joint metal/polymer or ceramic/polymer
semiconstrained resurfacing cemented prosthesis.

    (a) Identification. A hip joint metal/polymer or ceramic/polymer 
semi-constrained resurfacing cemented prosthesis is a two-part device 
intended to be implanted to replace the articulating surfaces of the hip 
while preserving the femoral head and neck. 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 includes prostheses that consist of a femoral cap 
component made of a metal alloy, such as cobalt-chromium-molybdenum, or 
a ceramic material, that is placed over a surgically prepared femoral 
head, and an acetabular resurfacing polymer component. Both components 
are intended for use with 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 January 3, 2005, for any hip joint 
metal/polymer or ceramic/polymer semiconstrained resurfacing cemented 
prosthesis that was in commercial distribution before May 28, 1976, or 
that has, on or before January 3, 2005, been found to be substantially 
equivalent to a hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any other hip joint metal/polymer or 
ceramic/polymer semiconstrained resurfacing cemented prosthesis must 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

[69 FR 59134, Oct. 4, 2004]