Gabrielle M. Lee (212) 527-7538
Jessica Masuga (574) 371-4830
DEPUY ORTHOPAEDICS RECEIVES FDA 510(k) CLEARANCE
FOR RECLAIM™ REVISION HIP SYSTEM
WARSAW, IN – February 14, 2011 – DePuy Orthopaedics, Inc. (DePuy) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the RECLAIM™ Revision Femoral Hip System in cementless hip revision surgery. Engineered to deliver a high level of implant strength, the RECLAIM™ System is a compelling solution for patients facing revision total hip replacement surgery.
“The RECLAIM Revision Hip System is designed to address clinical needs for patients facing complex revision total hip replacement procedures,” explained Mike Barker, Worldwide Vice President, Product Development, DePuy Orthopaedics, Inc. “This system has been studied extensively through analytic techniques and rigorous laboratory testing and has demonstrated very promising capabilities, particularly with respect to construct fatigue strength and torsional stability. We are very pleased to begin providing this exciting new treatment option to orthopaedic surgeons and the patients they treat.”
The modular design of the RECLAIM Revision Hip System features novel instrument technology which may improve intraoperative handling, flexibility, and efficiency. The modularity of the system offers surgeons numerous options to treat a patient’s unique pathology while simplifying the instrumentation required in surgery.
“The RECLAIM™ Hip System truly delivers a superb level of functionality and reproducibility for surgeons performing revision hip surgery,” said David Floyd, Worldwide President, DePuy Orthopaedics, Inc. “We believe that the RECLAIM Hip Stem, in conjunction with our PINNACLE® Acetabular Cup System, represents a meaningful advance in revision hip surgery.”
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. People with conditions limiting rehabilitation should not have this surgery. Patients should consult with an orthopaedic surgeon to determine if hip replacement surgery is appropriate for them.
About DePuy Orthopaedics
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities, and trauma, as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision – Never Stop Moving® – to express their commitment to bring meaningful innovation, shared knowledge, and quality care to patients throughout the world.