FDA Reclassifies Knee Joint Prostheses to Class II for Special Controls

Summary

The Food and Drug Administration (FDA) has reclassified two knee joint prostheses, the patellofemorotibial metal/polymer porous-coated uncemented prosthesis and the femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis, from class III to class II, requiring special controls to ensure safety and effectiveness, as outlined in the FDA's guidance document for industry and FDA.