The FDA has given marketing approval to Johnson & Johnson‘s DePuy Orthopaedics division for its PINNACLE CoMplete Acetabular Hip System. This is the first ceramic-on-metal hip implant to be available in the United States and it rounds out the PINNACLE line that already includes metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene and ceramic-on-ceramic implants.
The FDA approval of the CoMplete system was based in part on results from a two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing. As is typical for PMA approved devices, DePuy will commence a post-market study to monitor patients for short-, mid- and long-term safety and effectiveness.
The performance of a hip replacement depends on a patient’s age, weight, activity level and other factors. There are potential risks, and recovery takes time. The risks associated with the CoMplete system are similar to those of other hip replacement systems.
DePuy press release: FDA APPROVES FIRST CERAMIC-ON-METAL IMPLANT FOR HIP REPLACEMENT …