[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: 21CFR888.3330]

[Page 482]
 
                        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. 888.3330  Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    (a) Identification. A hip joint metal/metal semi-constrained, with 
an uncemented 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. The femoral component is intended to be fixed with bone 
cement. The acetabular component is intended for use without 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.