Intermedics PMA for cementless Natural Knee is approvable -- FDA panel.
This article was originally published in The Gray Sheet
Executive Summary
INTERMEDICS ORTHOPEDICS PMA FOR CEMENTLESS NATURAL KNEE needs additional benchtop fatigue testing data before it can be approved, FDA's Orthopedic and Rehabilitation Devices Panel concluded at a June 12 meeting in Gaithersburg, Maryland. The request for enhanced fatigue testing data, which the panel said should include additional comparisons to other prostheses, was one of several conditions placed on the advisory group's unanimous approvable recommendation for the premarket approval application. The panel's recommendation covered cementless implantation of the Natural Knee in patients suffering from either inflammatory joint disease or non-inflammatory degenerative joint disease.
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