OR WAIT 15 SECS
WASHINGTON -- The Food and Drug Administration (FDA) has reclassified two fixed-bearing knee joint prostheses, the patellofemorotibial and the femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis, from class III devices (i.e., premarket approval) to class II devices (i.e., special controls).
The special control that will apply to the patellofemorotibial prosthesis, used for whole knee joint replacement, and the femorotibial prosthesis, used for partial knee joint replacement, is titled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-coated Uncemented Prostheses; Guidance for Industry and FDA."
The FDA reasoned that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the devices. The rule was effective March 24, 2003. For more information, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/ 03-6857.html.