FDA Plans Orthopedic Device Panel Meeting

The U.S. Food and Drug Administration (FDA) has planned a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to make recommendations on the agency’s re-evaluation of the ReGen Collagen Scaffold device, which is manufactured by ReGen Biologics Inc., based in Franklin Lakes, N.J.

The FDA cleared the device, which was marketed as Menaflex, on Dec. 18, 2008, according to the Federal Register. The indications for use statement for this device stated that the device is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus.

ReGen Biologics is a manufacturer of minimally invasive implants.

For more information about the meeting, contact Tracy Phillips at the Center for Devices and Radiological Health at (301) 796-6150.