First Ceramic-On-Metal Implant for Hip Replacement recommended for approval by FDA advisory panel
The Orthopaedic and Rehabilitation Devices advisory committee has unanimously recommended the FDA approval of DePuy Orthopaedics’ Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal hip bearing to be considered for approval in the US. The recommendation was based on the clinical study comparing Pinnacle CoMplete System to a commonly used DePuy metal-on-metal implant on the efficacy and safety. Laboratory testing on the Pinnacle CoMplete System showed a greater than 90% reduction in wear compared to the metal-on-metal system under normal gait conditions and a more than 80% reduction in wear under adverse conditions.
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