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FDA clears Orthovita Vitoss Bimodal Bone Graft Substitute

Orthovita, an orthobiologics and biosurgery company, has received the US Food and Drug Administration (FDA) 510(k) clearance to market Vitoss BA Bimodal Bone Graft Substitute as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine.

In accordance with Orthovita‘s development, manufacturing and supply agreement with Kensey Nash, Orthovita would be obligated to pay Kensey Nash to manufacture the Vitoss BA Bimodal and also to make royal payments based on the net sales of the product.

Vitoss BA Bimodal contains Orthovita’s proprietary Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash Corporation’s proprietary collagen material.

Vitoss BA Bimodal differs from previous versions of Vitoss BA in size distribution of the bioactive glass particles to accelerate resorption of the bioactive glass.

Orthovita president and CEO Antony Koblish said surgeons need an array of spine and orthopedic bone grafting products with properties designed to fit the unique patient challenges that present each day.

"Our goal is to develop best in class orthobiologic products that meet these needs. By introducing a broader array of product offerings, we better serve the needs of patients, surgeons and hospitals," Koblish said.