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DePuy Orthopaedics receives 510(k) clearances for foot and hip fracture devices
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DePuy Orthopaedics, Inc. announced 510(k) clearances from the U.S. Food and Drug Administration 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, according to a company press release. 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, the release noted.
“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.”
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, according to the release.
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, the company noted.
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 1-mm 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 company stated in the release.