[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3027]

[Page 457]
 
                        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. 888.3027  Polymethylmethacrylate (PMMA) bone cement.

    (a) Identification. Polymethylmethacrylate (PMMA) bone cement 
(luting agent) is a device intended to be implanted that is made from 
methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid 
or copolymers containing polymethylmethyacrylate and polystyrene. The 
device is intended for use in arthroplastic procedures of the hip, knee, 
and other joints for the fixation of polymer or metallic prosthetic 
implants to the living bone.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 888.3.