The U.S. Food and Drug Administration (FDA) has ruled that an orthopedic device used in the knee should not have been cleared for marketing in the United States.

The determination was announced following a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the agency's review of the device.
To correct this error, FDA will begin the process to rescind the product's marketing clearance. Before beginning this process, the FDA has asked the product's manufacturer, ReGen Biologics Inc., for a meeting to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.

Initial clearance

FDA cleared the Menaflex Collagen Scaffold for marketing in December 2008 for the repair and reinforcement of the meniscal tissue in the knee. The meniscus is a C-shaped disk of fibrocartilage in the knee that acts as a cushion between the ends of bones in the joint and helps lubricate the joint.

The September 2009 report recommended a scientific re-evaluation of the device because the administrative record did not supply a basis for the FDA's December 2008 decision to clear that was adequate to dispel questions about the role of outside pressures on the review process.

This re-evaluation, initiated in the fall of 2009, included a team of scientists at the agency who were not involved in previous reviews of the device. Another advisory committee meeting was also held in March 2010 (pdf file).

Safety questions

The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called "predicate devices." 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. Because of these differences, the Menaflex device should not have been cleared by the agency.

It is unlikely that explanting the device will generally be appropriate or necessary because the device is resorbed and replaced with new tissue. However, patients who have had the Menaflex device implanted should talk with their surgeon or other health care professional about what, if any, steps should be taken.

Manufacturer's options

After implementing a rescission, which revokes a marketing clearance later determined to be erroneous, the FDA prohibits the manufacturer from further U.S. marketing until the agency approves or clears a new marketing application, or grants a classification petition.

After the FDA issues a rescission notice, a manufacturer has the option of requesting a regulatory hearing with the FDA or can choose to voluntarily withdraw their marketing clearance. The device will remain on the market until the agency rescinds its clearance.

The circumstances surrounding the Menaflex device are unique, and FDA's decision in this case does not affect the status of other devices on the market.