BioStructures announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for bioactive bone graft putty (Signafuse). Signafuse is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.
According to a press release, Signafuse represents a new class of synthetic biomaterials designed for optimisation of cell growth and bone formation. Signafuse is comprised of a biphasic mineral and bioactive glass suspended in a resorbable polymer carrier. The patented polymer carrier gives Signafuse exceptional handling characteristics which allow the graft to be easily moulded and shaped for the unique size of the bony defect.
Russell Cook, chief executive officer of BioStructures says, “We are very pleased to receive FDA clearance for Signafuse bioactive bone graft putty. This technology combines our proven biphasic mineral with our patented bioactive and polymer components. We realise the orthobiologic market is crowded with a plethora of commodity offerings, so we wanted to develop a unique and effective device that brings excitement to the surgeon community as well as our distribution partners.”