FDA grants premarket approval for new ceramic-on-ceramic total hip system
DePuy Orthopedics Inc. announced that the FDA has granted premarket supplement approval for its Ceramax Total Hip System with Biolox delta Ceramic-on-Ceramic 36-mm Large Femoral Head.
According to a company press release, this premarket supplement approval (PMA) for the 36-mm size follows the initial PMA approval of the Ceramax Hip 28-mm size in 2010. With the launch of the Ceramax System this summer, the company’s Pinnacle Acetabular Cup System will offer the only FDA approved ceramic-on-ceramic bearing surface with Biolox delta Femoral Head, a next generation nano composite ceramic material with high strength and toughness.
The Ceramax Hip System expands the Pinnacle Hip Solutions portfolio of high performance instruments, advanced implants, materials and solutions designed to provide surgeons flexibility in techniques and procedures and provide pain relief and a smooth range of motion for patients. In a clinical study of 264 patients who required hip replacement surgery for non-inflammatory degenerative joint disease, the researchers found no significant differences between the Ceramax System to a ceramic-on-polyethylene hip replacement in adverse events or survivorship. Patients also had similar pain relief and improved function and range of motion.
“DePuy Synthes Joint Reconstruction continues to advance bearing technology, design, materials and manufacturing to help surgeons choose products based on evolving patient demographics and needs,” Andrew Ekdahl, worldwide president of DePuy Synthes Joint and Reconstruction, stated in the release. “Ceramic-on-ceramic bearings represent nearly 20% of all bearings used outside the United States, and DePuy Synthes Joint Reconstruction is pleased to be able to bring the most advanced option in ceramic-on-ceramic technology — already available in several international markets — to patients in the United States.”