BioStructures, a privately held orthobiologics company, announced that the United States Food and Drug Administration has granted 510(k) clearance for its next generation MCS Bone Graft (Silhouette Mineralized Collagen Scaffold).
Silhouette represents a new class of synthetic biomaterials designed for optimized intra-operative handling and biologic responsiveness at the defect site.
Silhouette comprises a clinically proven bi-phasic mineral component suspended within a woven network of type I collagen fibers. The 90% porous matrix provides an interconnected structure optimized for the delivery of autogenic bone marrow aspirate and subsequent population of biologic factors essential to the healing process.
Silhouettes’ unique composition and structural properties deliver a bone graft that is tailored to support bone bonding and sustained remodeling as the healing process occurs.
Russell Cook, CEO of BioStructures said, "We are very pleased to receive FDA clearance for Silhouette Mineralized Collagen Scaffold. We founded BioStructures in 2009 with the goal to develop and commercialize proprietary first-in-class products in the bioactive, polymer, collagen and cellular bone graft spaces.
"The Silhouette clearance represents the third step in our attainment of that goal. Looking forward, we will continue to develop our pipeline of products in a continued effort to offer a unique breadth of products all under the BioStructures umbrella."
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.