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DePuy receives FDA 510(k) clearance for revision hip system

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DePuy Orthopaedics, Inc. announced in a press release that it has received 510(k) clearance from the FDA for use of the RECLAIM Revision Femoral Hip System in cementless hip revision surgery.

“The RECLAIM Revision Hip System is designed to address clinical needs for patients facing complex revision total hip replacement procedures,” Mike Barker, worldwide vice president of product development for DePuy Orthopaedics, Inc., stated in a press release. “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.”

According to a DePuy press release announcing the news, 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,” David Floyd, worldwide president of DePuy Orthopaedics, Inc., stated in the release. “We believe that the RECLAIM Hip Stem, in conjunction with our PINNACLE Acetabular Cup System, represents a meaningful advance in revision hip surgery.”