Shoulder joint prostheses
This article was originally published in The Gray Sheet
Executive Summary
Metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prostheses should be reclassified from Class III into Class II, FDA tentatively concludes in a May 28 Federal Register notice requesting comments on the decision. FDA identifies infection, adverse tissue reaction, pain and/or loss of function, and revision as potential risks to health. In affirming that special controls would reasonably assure the safety and effectiveness of the devices, the agency largely agrees with the recommendation put forth by the Orthopedic and Rehabilitation Devices Panel in January 1998 ("The Gray Sheet" Jan. 26, 1998, p. 8). However, FDA disagrees with the panel's recommendation that postmarket surveillance be used to track adverse device outcomes. Comments are due Aug. 26