Full article reprinted from "The Gray Sheet" - November 10, 2008
Find out how FDA's Orthopaedic and Rehabilitation Devices Panel will meet Nov. 14 to review an updated 510(k) submission for ReGen Biologics' Collagen Scaffold knee cartilage repair product.
ReGen Biologics is hoping that the third time will be the charm for the device, for which two previous 510(k)s were rejected by FDA due to insufficient data, most recently in September 2007.
The implantable surgical mesh is intended to repair and reinforce meniscal defects that occur not only as a result of age, but also from intense athletic activities. The collagen implant serves as a matrix for, and is gradually replaced by, the patient's own tissue.
In July, the firm submitted an updated 510(k) after releasing results of a 331-patient study comparing its implant technology, also known as Menaflex, with partial meniscectomy ("1The Gray Sheet" July 28, 2008, p. 27).
The randomized study concluded that use of the technology resulted in a statistically significant increase in new tissue within the meniscus for patients with both acute and chronic meniscus injuries. It also found that patients with one to three prior meniscus injuries regained significantly more pre-injury activity, and had fewer meniscus-related reoperations, than the control group.
In the wake of FDA's 2007 "not substantially equivalent" determination, ReGen Biologics had suggested that a lack of sports medicine specialists at FDA's orthopedic devices review branch was behind the rejection ("2The Gray Sheet" Oct. 1, 2007, p. 17).
FDA's notice of the upcoming panel meeting was published in the Nov. 4 Federal Register. "Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of [the panel] were available at this time, the Commissioner ... concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice," FDA explained.
- Sue Darcey
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