[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: 21CFR888.3320]

[Page 481]
 
                        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. 888.3320  Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

    (a) Identification. A hip joint metal/metal semi-constrained, with a 
cemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular 
component, both made of alloys, such as cobalt-chromium-molybdenum. This 
generic type of device is limited to those prostheses 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.

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