Bone Graft Substitute Receives FDA Clearance

(NIH)

Orthovita Inc., an orthobiologics and biosurgery device developer in Malvern, Pennsylvania, says it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Vitoss Bioactive Foam-2X bone graft substitute as a non-structural bone void filler for use in the spine, pelvis, and extremities. The company says it expects to launch the this new product by late February or early March of 2011.

Compared to its current Vitoss Bioactive Foam Bone Graft Substitute products, Orthovita says, the Vitoss Bioactive Foam-2X product has the same structure and porosity but contains increased levels of bioactive glass, which in-vitro testing has shown induces two times the deposition of calcium phosphate growth onto the surface of the implant, while retaining the same handling properties.

Section 510(k) of the Food, Drug and Cosmetic Act requires medical device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance, particularly for devices introduced into commercial distribution for the first time or those reintroduced that will be significantly changed or modified to the extent that their safety or effectiveness could be affected. Such changes or modifications could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

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