Posted by Michael Wonder on 16 Feb 2022
Bonalive Biomaterials granted FDA breakthrough device designation for a bone graft substitute that potentially protects against microbial colonisation
16 February 2022 - The Center for Devices and Radiological Health at the U.S. FDA has determined that Bonalive Orthopedics granules, made of a unique S53P4 bioactive glass, qualifies for designation as a breakthrough device.
Proposed indications for use include filling of bony voids and gaps, and potentially protecting against microbial colonisation while the granules resorb and are replaced with bone during the healing process.
