Synthetic Bone Replacement Cleared by FDA

A synthetic bone void filler designed for repairing bone defects in the spine, extremities, and pelvis has been cleared by the U.S. Food and Drug Administration (FDA). The bone replacement eliminates the need for additional surgery to retrieve a graft of a patient's own bone.

Called Vitoss, the synthetic bone is the product of Orthovita (Malvern, PA, USA). It is based on the company's solution-based chemistry, resulting in a highly porous scaffold to support bone growth. Vitoss is composed of nanometer-sized calcium phosphate particles with 90% interconnecting porosity and is available as a scaffold matrix both in morsel and block forms. Because it is synthetic, concerns about product availability, purity, or potential for rejection are eliminated. The physical structure and technology behind Vitoss replicates human bone and allows for the flow of marrow, blood, and nutrients required for bone growth and accelerated healing, says Orthovita.

"Combining Vitoss with bone marrow, rich in stem cells, allows us to create a structure that maintains critical porosity and biologic activity,” said Robert Gunzburg, M.D., executive member of the Spine Society of Europe.



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