FDA Clears New Bioactive Bone Graft Putty and Bone Graft Extender from BioStructures

Orthobiologics company BioStructures, LLC, has seen its Signafuse™ Bioactive Bone Graft Putty granted U.S.FDA 510(k) clearance. Signafuse™ is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.

Background

BioStructures is a leading medical device company focused on developing innovative proprietary platforms in bioresorbable bone graft products for a broad range of spinal and orthopedic fusion procedures.

Signafuse™ represents a new class of synthetic biomaterials which its manufacturer says is 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.

Company comments

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.”

Source: BioStructures, LLC., PR Newswire

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