DePuy Gets FDA Approval for Ceramic-On-Metal Hip Replacement

The first ceramic-on-metal total artificial hip system has been approved by the U.S. Food and Drug Administration (FDA) for patients with osteoarthritis. The Pinnacle CoMplete Acetabular Hip System, manufactured by DePuy Orthopaedics, Inc., is the first to use a ceramic ball and a metal socket.

“Orthopedic surgeons and their patients now have an additional option for total hip replacement with the approval of the Pinnacle CoMplete Acetabular Hip System,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

The approval is based on a two-year randomized clinical trial that found no clinical difference between 194 patients who received the ceramic-on-metal hip system and 196 patients who received a metal-on-metal system. Two patients in the experimental group required a second surgery to replace their new implant, compared with three patients in the control group (given the metal-on-metal system).

Warsaw, Ind.-based DePuy will conduct a post-market study of patients who receive the Pinnacle CoMplete System for adverse events and metal ion concentrations in the bloodstream.

“The CoMplete system offers durability and stability, along with enhanced low-wear characteristics, that will provide surgeons with an important new option for patients with severe osteoarthritis,” said Randy Kilburn, Vice President, U.S. Marketing, DePuy Orthopaedics, Inc. “This addition to the Pinnacle platform, when available, will provide surgeons with the freedom to choose the bearing combination, whether it is metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or ceramic-on-metal, that best meets the patient’s individual needs.”