Intermedics Orthopedics' knee gets favourable panel review
This article was originally published in Clinica
Executive Summary
Intermedics Orthopedics' (US) Natural Knee prosthesis received a unanimous recommendation for conditional US marketing approval by the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel on June 12th. The recommendation was for cementless use of the implant in skeletally mature individuals. The panel recommended that Intermedics be required to perform additional ex vivo studies to measure the ability of the prosthesis to withstand shear forces and to perform post- marketing follow-up studies in patients.