Corin’s Cormet hip destined for panel
This article was originally published in The Gray Sheet
Executive Summary
FDA's Orthopedic & Rehabilitation Devices Panel will likely convene in the first quarter of 2007 to consider Corin's Cormet metal-on-metal resurfacing hip, though an exact date has not yet been set, according to the company's Nov. 1 release. A PMA was submitted for the device in March 2005. FDA has initiated inspection of Corin's UK facility, which should wrap up by the end of the month, the firm says, adding that Cormet, to be sold by Stryker under a 10-year distribution agreement, has been implanted in 12,000 patients worldwide since 1997...