New Indication for Orthovita’s Vitoss Bone Graft Substitute

The U.S. Food and Drug Administration (FDA) has given its OK to a new version of Orthovita’s Vitoss bone graft substitute.

The company received 510(k) clearance to market its Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March.

Compared to current Vitoss Bioactive Foam Bone Graft Substitute products, the latest version has the same structure and porosity but contains increased levels of bioactive glass, which, according to the company, has been shown by in-vitro testing to induce twice the deposition of calcium phosphate growth onto the surface of the implant, while retaining the same handling properties.

“We believe that the combination of increased bioactivity and our unique scaffold design will support more effective bone formation than before,” said Antony Koblish, president and CEO.

Orthovita will pay Exton, Pa.-based Kensey Nash to manufacture the graft. The company also will make royalty payments to Kensey Nash based on the net sales of the product.

Orthovita, Inc. is a specialty spine and orthopedic company based in Malvern, Pa., with a portfolio of orthobiologic and biosurgery products.