FDA Acts to Remove 510(k) Clearance for ReGen’s Menaflex Knee Implant

The FDA is now officially moving forward with plans to rescind the 510(k) for ReGen Biologics’ Menaflex knee implant. The decision brings to an end the company’s five-year struggle to commercialize the Menaflex Collagen Scaffold. “The [FDA] today announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States,” the agency said Thursday. “To correct this error, the agency will begin the process to rescind the product’s marketing clearance.”
Devices & Diagnostics Letter