DEPUY ORTHOPAEDICS, INC. RECEIVES FDA PMA SUPPLEMENT APPROVAL FOR CERAMAX® TOTAL HIP SYSTEM WITH BIOLOX® delta CERAMIC-ON-CERAMIC 36MM LARGE FEMORAL HEAD
New Ceramic-on-Ceramic Option Provides Additional Choice within PINNACLE® Hip Portfolio in the U.S.
WARSAW, IN – May 3, 2013 – 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 prospective, multi-center, non-randomized, controlled clinical study of 264 patients who required hip replacement surgery for non-inflammatory degenerative joint disease 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, improved function and range of motion.3 The FDA concluded that the CERAMAX System was safe and effective.
“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.
For more information about hip replacement, visit the DePuy Synthes Joint Reconstruction website: http://www.hipreplacement.com.
About DePuy Synthes Joint Reconstruction
DePuy Synthes Joint Reconstruction Division, a global leader in hip, knee and shoulder replacement, is part of the DePuy Synthes Companies of Johnson & Johnson, the largest provider of orthopaedic and neurological solutions in the world. (This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Orthopaedics, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; and manufacturing difficulties or delays. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Orthopaedics, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
1.http://www.ceramtec.com/index/divisions/medical_products/orthopaedic_companies/materials/material_properties_of_biolox_delta/mechanical_properties/04157,0125,0358,4178.php 2. DePuy Orthopaedics, Inc. DePuy Ceramax™ Ceramic Total Hip System. “Information for Prescribers – Safety and Effectiveness Results.” 3. Data on file, DePuy Orthopaedics, Inc.