Orthopedic Devices; Reclassification of the Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis and the Knee Joint Femorotibial (Uni-compartmental) Metal/Polymer Porous-Coated Uncemented Prosthesis

概要

The Food and Drug Administration (FDA) is announcing for public comment two recommendations of the Orthopedic and Rehabilitation Devices Panel (the Panel) to reclassify the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and the knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis from class III into class II. The Panel made these recommendations after reviewing the reclassification petition submitted by the Orthopedic Surgical Manufacturers Association (OSMA) and other publicly available information. FDA is also announcing for public comment its tentative findings on the Panel's recommendations. After considering any public comments on the Panel's recommendations and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register.