[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: 21CFR888.3480]

[Page 484-485]
 
                        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. 888.3480  Knee joint femorotibial metallic constrained cemented prosthesis.

    (a) Identification. A knee joint femorotibial metallic constrained 
cemented prosthesis is a device intended to be implanted to replace part 
of a knee joint. The device prevents dislocation in more than one 
anatomic plane and has components that are linked together. The only 
knee joint movement allowed by the device is in the sagittal plane. This 
generic type of device includes prostheses that have an intramedullary 
stem at both the proximal and distal locations. The upper and lower 
components may be joined either by a solid bolt or pin, an internally 
threaded bolt with locking screw, or a bolt retained by circlip. The 
components of the device are made of alloys, such as cobalt-chromium-
molybdenum. The stems of the device may be perforated, but 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 December 26, 1996 for any knee 
joint femorotibial metallic constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a knee 
joint femorotibial metallic constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other knee joint 
femorotibial metallic constrained cemented prosthesis shall have an 
approved PMA or a

[[Page 485]]

declared completed PDP in effect before being placed in commercial 
distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]