Menaflex collagen meniscus implant regulatory update

FDA said it will rescind marketing clearance for ReGen's Menaflex collagen meniscus implant. In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue injuries. FDA released a report recommending a reevaluation of the approval of a 510(k) application for the resorbable collagen scaffold to re-grow meniscus cartilage because the review process had been influenced by outside pressures. FDA said a review of the application found that Menaflex is intended for different uses and is technologically dissimilar from already marketed "predicate" devices, and thus should not have been approved (see BioCentury, Sept. 28, 2009 & March 29). ...