Prosthesis and Orthopedy
Vitoss is a bestselling synthetic bone graft substitute composed of 100 nm β-tricalcium phosphate (β-TCP, Ca3[PO4] 2) nanocrystals approved by the FDA in 2003 through 510(k) pathway; an approval mechanism for medical devices. Vitoss is able to mimic the structure of cancellous bone (also known as spongy or trabecular bone) and can fill voids or gaps in the skeletal system. Vitoss is synthesized by a high temperature calcination process and contains porous granules of 1–4 mm diameter. Another formulation, Vitoss Bioactive, includes conventional Vitoss combined with a bioactive agent to enhance bone remodeling speed. Stryker Company (which acquired Orthovita, Inc. in 2011) also launched Vitoss BBTrauma in 2012 which consists of bioactive glass particles with a higher surface area.