Extremity Medical, LLC Receives FDA Approval on the IOFiX Foot and Ankle System.
Extremity Medical, LLC (Parsippany, NJ) announced today that it has received 510K clearance from the FDA on the IOFiX Intraosseous Fixation System for performing a variety of procedures in the foot and ankle. The company also announced that the CE Mark has been received for this product.
This comprehensive system provides a completely new method for delivering compression and stable fixation for fusion of many troublesome joints in the foot, and requires smaller incisions. “This system has been designed to fill a large void in foot and ankle surgery by applying the well-accepted principles of intramedullary fixation,” stated Christopher DiGiovanni, MD (Professor and Chief of the Division of Foot and Ankle Surgery in the Department of Orthopaedic Surgery, Brown University/Rhode Island Hospital in Providence, RI). “While these concepts have enjoyed amazing success in other parts of the musculoskeletal system, they
have never really been adapted to, nor taken advantage of, by foot and ankle specialists. Our intention is for these foot-specific devices to offer the surgeon a significantly improved modularity, ease of use, and construct rigidity capable of facilitating many surgical techniques involving trauma and reconstructive surgery of the forefoot, midfoot, and/or hindfoot —all in one set. We anticipate that the introduction of intramedullary fixation to the foot will continue to evolve into less complicated, more stable, and lower profile fixation than can otherwise now be obtained. We are also very excited about the potential this technology offers in performing these procedures through smaller and smaller incisions with increasingly less soft tissue dissection and hardware prominence, as well as hopefully enabling faster progression to weight bearing in the post-op setting, much akin to what has already been realized with the traditional IM devices currently in use in other areas.
Judy Baumhauer, MD MPH (Professor – Orthopedics, University of Rochester School of Medicine and Dentistry, Rochester, NY) added, “Through thoughtful design, Extremity Medical has delivered a unique, comprehensive and modular system that can be used routinely across a variety of foot and ankle conditions.”
Extremity Medical is planning a limited launch of the product in selected centers across the U.S. and in Europe in Q4 2010, and has plans for entering many international markets in 2011.
Jamy Gannoe (President and Co-Founder of Extremity Medical) stated “Introduction of this product further demonstrates our commitment to delivering useful and different products with new, clinically beneficial functions. The IOFiX Foot and Ankle System complements the HalluX, TarsX, and IOFiX MCP Intramedullary Fixation Systems and adds to a growing portfolio of specialized devices specific to the needs of distal extremities surgeons.”
