Constrained Hip Prostheses Downclassification Backed For No-Option Cases
This article was originally published in The Gray Sheet
Executive Summary
Labeling for constrained metal/polymer hip joint prostheses should clearly indicate that the devices be used only when "all other options have been exhausted," FDA's Orthopedic and Rehabilitation Devices Panel recommended Nov. 4 as a condition for downclassifying the devices into Class II.