GAITHERSBURG, Maryland – The PMA for Durolane, a hyaluronic acid product intended for use as a single-injection treatment for osteoarthritis-induced pain in the knee, tanked in Wednesday's hearing of the orthopedic and rehabilitative devices advisory committee due to the failure to convince the panel of the device's efficacy. The panel grew a case of the jitters regarding efficacy in part because of the use of three trials the company conducted in support of the application, but the last of the three trials used a corticosteroid injection for controls, a move FDA went along with then criticized during the panel hearing. (Medical Device Daily)

GAITHERSBURG, Maryland — The definition of "first-of-kind device" is not the same for everyone, but a combination of 510(k) components that brings together materials that have not previously been mated constitute a new device for FDA. That was one lesson from Tuesday's meeting of the orthopedic and rehabilitative devices advisory committee, which reviewed the PMA for the CoMplete acetabular hip system made by DePuy Orthopedics (Warsaw, Indiana). (Medical Device Daily)