IsoTis Receives FDA 510(k) Clearance for DynaGraft II

IsoTis OrthoBiologics has received 510(k) clearance from the FDA for its DynaGraft II product family for orthopedic applications.

DynaGraft II, one of the products in IsoTis' portfolio of bone graft substitutes, is derived from demineralized bone matrix (DBM) and delivered in a reverse phase medium for optimal graft containment.

DynaGraft II is a combination of DBM in a reverse phase medium. The reverse phase medium becomes more viscous at body temperature, but less viscous at cooler temperatures. Therefore, it is malleable at operating room temperatures, but stiffens when placed in the operative site. This allows the DBM to be contained at the graft site with minimal loss through irrigation and suction.