Ceramax® Total Hip System With Biolox® Delta Ceramic-On-Ceramic 36mm Large Femoral Head Receives FDA PMA Supplement Approval
New Ceramic-on-Ceramic Option Provides Additional Choice within PINNACLE® Hip Portfolio in the U.S.
DePuy Orthopaedics, Inc. has received Pre-Market (PMA) Supplement Approval from the U.S. Food and Drug Administration (FDA) for the DePuy CERAMAX® Total Hip System with BIOLOX® delta Ceramic-on-Ceramic 36MM Large Femoral Head. DePuy Synthes Joint Reconstruction is a division of DePuy Orthopaedics, Inc.
This PMA supplement approval for the 36mm size follows the initial PMA approval of the CERAMAX Hip 28mm size in 2010. Upon 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 new, next generation nano composite ceramic material.
The key benefits of BIOLOX delta Ceramic Head are its very high strength and toughness. These properties are achieved as a result of the high density of the material and the very small grain size of the alumina matrix.1 Since 1974, previous versions of BIOLOX Ceramic Heads have been used in millions of implants throughout the world.2
“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,” said Andrew Ekdahl, Worldwide President, DePuy Synthes Joint Reconstruction. “Ceramic-on-ceramic bearings represent nearly 20 percent of all bearings used outside the U.S., 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 U.S.”
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. The PINNACLE Acetabular Cup System, the most widely used acetabular cup in the world, has been provided for more than 1 million patients worldwide.
The safety and effectiveness of the CERAMAX System was evaluated in a blinded, randomized prospective study of 264 patients who required hip replacement surgery for severe osteoarthritis that compared the CERAMAX System to ceramic-on-polyethylene hip replacement. The study, which was part of the company’s PMA application, found no significant differences in adverse events or survivorship between the two groups, and patients experienced similar pain relief, and improvement of function and range of motion.3 The FDA concluded that the benefits of the CERAMAX System outweigh the risk of surgery when used with appropriate patients.
“The CERAMAX System provides surgeons and their patients with an additional option that has met the demands of a rigorous PMA process using a combination of the PINNACLE Cup System and the CERAMAX ceramic liner and femoral head,” said Dr. Simon Sinclair, Worldwide Vice President of Strategic Medical Affairs, DePuy Synthes Joint Reconstruction. “What makes this product unique is the combination of PINNACLE’s modular bearing system and the use of BIOLOX delta Ceramic Head. Previous generations of BIOLOX Ceramic Heads have been used to bring benefit to patients, and a next generation BIOLOX Ceramic Head material is now available in additional sizes to accommodate more patients.”
The performance of hip replacements depends on age, weight, activity level and other factors. There are potential risks and recovery takes time. People with conditions limiting rehabilitation should not have this surgery. Only an orthopaedic surgeon can determine if hip replacement is right for a patient.
1. ceramtec.com – BIOLOX®delta
2. DePuy Orthopaedics, Inc. DePuy Ceramax™ Ceramic Total Hip System. “Information for Prescribers – Safety and Effectiveness Results.”
3. Data on file, DePuy Orthopaedics, Inc.