BioStructures Receives 510(k) Clearance for Bone Graft Putty

The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to BioStructures LLC’s Bioactive Bone Graft Putty Signafuse. The material is designed for use in 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, according to BioStructures. The material 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, company executives claim.

“We are very pleased to receive FDA clearance for Signafuse Bioactive Bone Graft Putty. This technology combines our biphasic mineral with our patented bioactive and polymer components.”
BioStructures CEO Russell Cook said. “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.”

BioStructures is a privately held orthobiologics company that develops bioresorbable bone graft products for various spinal and orthopedic fusion procedures. The firm is headquartered in Newport Beach,Calif.