Extremity Medical announces that it has received 510K clearance from the FDA for the company’s IOFiX MCP Intraosseous Fixation System.
Extremity Medical, LLC (Parsippany, NJ) announced today that it has received 510K clearance from the FDA for the company’s IOFiX MCP Intraosseous Fixation System for arthrodesis of the Metacarpal Phalangeal joints in the hand. The company also announced that it had received CE Mark for the product and was commencing limited release in the U.S. and in selected European and international markets. This represents the first product for the hand that utilizes intraosseous fixation for fusion of joints in the hand. This unique system offers the ability to fuse with a stronger construct and greater compression than traditional methods. The system also allows for a fixed angle and avoids complications resulting from irritation from plates, screws and wires.
Brian Adams, MD, who collaborated on the design of the product, commented “In addition to significant biomechanical strength advantages, the device offers benefits of intramedullary fixation where traditionally, pins, plates or tension band wiring were used but were commonly associated with hardware related irritation.”
Jamy Gannoe, Co-Founder and President of Extremity Medical, added “The release of the IOFiX MCP product strengthens our portfolio of intraosseous fixators and strengthens our position as an emerging innovative force in extremities.”
