Extremity Medical Receives FDA Clearance, CE Mark for IOFiX Fixation System

Parsippany, N.J.-based Extremity Medical, an orthopedic device company, announced the 510(k) clearance from the U.S. Food and Drug Administration of the company’s IOFiX MCP Intraosseous Fixation System for arthrodesis of the metacarpal phalangeal joints in the hand, according to an Extremity Medical news release.

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The company also announced that it had received CE Mark for the product and was starting a limited release in the U.S. and in selected European and international markets, according to the release.

The IOFiX MCP is first product that utilizes intraosseous fixation for fusion of joints in the hand, according to the release. This system also offers the ability to fuse with a stronger construct and greater compression than traditional methods and allows for a fixed angle and avoids complications resulting from irritation from plates, screws and wires.

Jamy Gannoe, co-founder and president of Extremity Medical, said in the release, “The release of the IOFiX MCP product strengthens our portfolio of intraosseous fixators and strengthens our position as an emerging innovative force in extremities.”

Read the release about the clearance of Extremity Medical’s IOFiX Fixation System (pdf).

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