FDA clears Orthovita's Vitomatrix dental bone graft substitute
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Orthovita's Vitomatrix, a bone graft substitute that can be used in certain dental procedures. This includes operations to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. The product is a resorbable porous synthetic scaffold that uses the same technology as the firm's Vitos bone graft substitute line. Vitomatrix could be used in around 375,000 procedures per year in the US, Malvern, Pennsylvania-based Orthovita estimates. The firm is currently evaluating potential commercial partners to distribute the product or license the underlying technology.