Cortoss goes 510(k) route
This article was originally published in The Gray Sheet
Executive Summary
FDA informs Orthovita that its Cortoss bone augmentation material for vertebroplasty can be reviewed via 510(k) with supporting clinical data rather than through the more burdensome PMA route. Orthovita is nearing completion of enrollment in its randomized pivotal trial comparing Cortoss with polymethylmethacrylate bone cement for osteoporotic vertebral compression fractures. The trial's goal is 255 patients enrolled with at least 162 patients receiving Cortoss with two-year follow-up. The firm plans further discussions with FDA "concerning the length of follow-up data required for the regulatory submission," Orthovita says. The product gained European clearance in January 2003 for screw and vertebral augmentation in VCF...