Orthovita to Pursue 510(k) for Cortoss, Despite Pivotal Study
BY LAUREN UZDIENSKI, FEBRUARY 5, 2007
Orthovita announced this morning that they would apply for 510(k) approval for their Cortoss® Bone Augmentation Material, scrapping a bid for PMA approval. Cortoss is not available in the U.S., but the product has a CE mark in Europe.
Applied in verteboplasty, Cortoss is currently being evaluated in the U.S. in a pivotal IDE study. Orthovita expects enrollment to be completed soon, particularly since a study design modification last April was expected to speed up the process. If completed as designed, the pivotal will have enrolled 255 patients at 22 sites for a 24-month follow-up. Orthovita says in their press release that they plan to discuss with the FDA appropriate follow-up for a 510(k) application. Less costly and time-consuming than a PMA, a 510(k) could also set a precedent for competitors seeking to market similar products.
