FDA Rescinds Marketing Clearance for Menaflex
The U.S. Food and Drug Administration (FDA) announced Oct. 14 that the Menaflex® Collagen Scaffold (an orthopedic device used in the knee) should not have been cleared for marketing in the United States. To correct this error, the agency intends to rescind the product’s marketing clearance.
The announcement follows a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the agency’s December 2008 review of the device, at which time the device was cleared for marketing by the FDA for the repair and reinforcement of the meniscal tissue in the knee.
The meniscus is a C-shaped disk of cartilage in the knee that acts as a cushion between the ends of bones in the joint and helps lubricate the joint.
The FDA has concluded that the Menaflex Collagen Scaffold (CS) device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called “predicate devices.” According to the FDA, these differences can affect the safety and effectiveness of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed.
Consequently, the FDA has determined that the clearance of the device was in error “based on the fact that the CS device does not have the same intended use as any of the identified predicate devices,” Jeffrey Shuren, M.D., J.D., director, Center for Devices and Radiological Health, said in a letter to the product’s manufacturer, ReGen Biologics Inc.
The FDA is not recommending orthopedic surgeons explant the device “because the device is resorbed and replaced with new tissue.” Instead, surgeons or other health care professionals should inform their patients and discuss what, if any, steps should be taken.
The Menaflex CS device will remain on the market until the agency officially rescinds its clearance. Once the FDA implements the rescission, the manufacturer may not conduct further U.S. marketing until the agency approves or clears a new marketing application, or grants a classification petition. The manufacturer has the option of requesting a regulatory hearing with the FDA or can choose to voluntarily withdraw their marketing clearance.
Source: FDA press release