MALVERN, Pa.--(BUSINESS WIRE)--Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced today that it has submitted a 510(k) filing to the U.S. Food and Drug Administration for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation. This filing is based on data collected in three U.S. clinical investigations conducted under FDA Investigational Device Exemptions (IDEs) and several European studies, and is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The extensive clinical study of CORTOSS demonstrates that the same degree of clinical improvement in pain and function is achieved with approximately 40% less material than PMMA when augmenting the vertebral body. CORTOSS also provides other benefits, including consistent handling characteristics and viscosity.
