US-based orthobiologics company BioStructures has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Signafuse bioactive bone graft putty, indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.
The Signafuse bioactive bone graft putty has a biphasic mineral and bioactive glass suspended in a patented resorbable polymer carrier.
The polymer carrier gives Signafuse exceptional handling characteristics which allow the graft to be easily molded and shaped for the unique size of the bony defect.
According to BioStructures, the new bioactive bone graft putty represents a new class of synthetic biomaterials designed for optimization of cell growth and bone formation.
BioStructures CEO Russell Cook noted the company is 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," Cook added.
"We realize 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."