BioStructures, LLC, a privately held orthobiologics company, today announced that the United States Food and Drug Administration 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.
Signafuse™ represents a new class of synthetic biomaterials designed for optimization 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 molded and shaped for the unique size of the bony defect.
Russell Cook, CEO of BioStructures said, "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 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."