FDA clears Synergy Biomedical’s BioSphere Flex bone graft

Synergy Biomedical has received FDA 510(k) clearance for its BioSphere Flex bone graft product.

The BioSphere Flex is a strip-format bone graft product that features porous, bioactive glass that is dimensionally integrated within a collagen and sodium hyaluronate scaffold. It porosity was designed to absorb bone marrow aspirate.

“The FDA clearance of BioSphere Flex adds a key product to Synergy’s synthetic bone graft portfolio,” Mark Borden, president and CEO of Synergy BioMedical, said in a press release. “The BioSphere product line provides surgeons with a full spectrum of bone graft forms that can be tailored to a variety of surgical techniques while leveraging the proven advantages of Synergy’s core bioactive technology. These options include BioSphere Putty (a robust bone graft material that can be used alone or combined with autograft), BioSphere MIS Putty (with a delivery system specifically designed for targeted graft placement in minimally invasive surgery) and now BioSphere Flex (developed to be used by surgeons who prefer the characteristics of a flexible strip form and the ability to augment with bone marrow aspirate).”

BioSphere Flex uses the company’s BioSphere technology that is based on a spherical form of bioactive glass that enables precise control over the osseous healing process. The granules used in the Flex have a bonded sphere structure that gives optimal porosity for bone growth through the granules. The implant is also flexible and moldable with hydrated with bone marrow aspirate which helps in graft placement and allows the implant to conform to irregular bone surfaces for maximum graft continuity and healing.

“The addition of BioSphere Flex to the product portfolio provides Synergy increased coverage of the bone graft market,” Kevin Booth, VP of sales, said. “With the BioSphere product line, surgeons have access to the next-generation bone graft technology that is compatible with a variety of bone grafting techniques.”