BioStructures received 510(k) clearance for bioactive bone graft putty

The FDA issued 510(k) clearance to BioStructures LLC for its Signafuse bioactive one graft putty, which is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.

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 allows the graft to be molded and shaped for the unique size of the bony defect, according to a company press release.

“This technology combines our proven biphasic mineral with our patented bioactive and polymer components,” Russell Cook, chief executive officer of BioStructures, stated in the release. “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.”