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DEPUY ORTHOPAEDICS RECEIVES 510(k) CLEARANCES FOR NEW DEVICES FOR FOOT AND HIP FRACTURE SURGERY - DePuy

 
WARSAW, IN – March 28, 2011 – DePuy Orthopaedics, Inc. (DePuy), a global leader in devices for joint replacement and trauma, today announced 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the A.L.P.S. Total Foot System and the AFFIXUS™ Hip Fracture Nail System.
 
The A.L.P.S. Total Foot System is a next generation system of anatomic plates designed specifically for foot surgery and the AFFIXUS Nail System is a new set of short and long nail and screw options and instrumentation for the treatment of proximal femoral fractures. Both systems are designed to help surgeons accommodate individual anatomic variation in patients.
 
In addition to receiving 510(k) clearances for the A.L.P.S. Total Foot and AFFIXUS Nail Systems, DePuy also announced the launch of GLOBAL® ADVANTAGE®+, a new instrumentation system for shoulder replacement surgery for use with the company’s GLOBAL® ADVANTAGE® shoulder replacement implant.
 
“DePuy Orthopaedics has invested heavily to engineer solutions that help surgeons address the individual needs of patients facing foot, hip or shoulder surgery,” explained Gordon Van Ummersen, Worldwide President of Trauma and Extremities, DePuy Orthopaedics, Inc. “These new devices represent significant advances in technology and surgical efficiency.”
 
A.L.P.S. Total Foot System
The A.L.P.S. Total Foot System includes nine anatomically contoured plates and both locking and non-locking screw options for use in reconstructive and trauma procedures of the forefoot, midfoot and hindfoot. The new plating technology enables intra-operative customization to accommodate patient-specific anatomy without compromising strength. Advanced screw technologies in the system offer surgeons the ability in select plates to choose from up to five different screw options for the locking holes.
 
AFFIXUS Hip Fracture Nail System
The AFFIXUS Hip Fracture System offers an extensive range of neck and shaft angles, distal diameters, nail lengths and locking options to help surgeons better customize procedures to address the variations in individual patient anatomy. The system, which is used with a single set of user-friendly instruments, combines the principles of a compression hip screw with the biomechanical advantages of an intramedullary nail.
GLOBAL ADVANTAGE+ Instrumentation for Shoulder Replacement Surgery
GLOBAL ADVANTAGE+ is a new set of humeral preparation instruments designed for ease of use and to enhance versatility, speed and precision in shoulder replacement procedures. Instruments include new 1mm increment humeral reamers for a more precise implant fit, a resection guide for greater accuracy, and a faster eccentric head trialing technique. GLOBAL® CTA™ (cuff tear arthropathy) instrumentation is also being added to the core set of instruments. 
 
The performance of joint reconstructive and joint replacement products 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 these surgeries. Patients should consult with an orthopaedic surgeon to determine if joint reconstruction and replacement surgery is appropriate for them.
 
About the DePuy Companies
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.
 

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Sep 08 2014 - 17:49:10