US FDA committee backs approval of DePuy Orthopaedics' Pinnacle CoMplete Acetabular Hip System

DePuy Orthopaedics, Inc, a global leader in devices for joint replacement, announced that the Orthopaedic and Rehabilitation Devices Advisory Committee of the US Food and Drug Administration (FDA) has unanimously recommended FDA approval of the Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal hip bearing to be considered for approval in the US. 

The panel's recommendation was based in part on results from a two-year controlled, randomized, blinded, prospective, multicenter, non-inferiority clinical study and laboratory testing that compared the safety and effectiveness of the Pinnacle CoMplete System to a commonly used DePuy metal-on-metal implant.