[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3410]

[Page 475]
 
                        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 semi-constrained resurfacing cemented prosthesis.

    (a) Identification. A hip joint metal/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 alloy, such as cobalt-chromium-molybdenum, 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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.