[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3027]

[Page 495]
 
                        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 is a 
device intended to be implanted that is made from methylmethacrylate, 
polymethylmethacrylate, esters of methacrylic acid, or copolymers 
containing polymethylmethacrylate 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 
living bone.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.''

[67 FR 46855, July 17, 2002]