FDA Designates Bonalive Biomaterials’ Bone Graft Substitute a Breakthrough Device

Bonalive Biomaterials’ bone graft substitute orthopedic granules have received the FDA’s Breakthrough Device designation.

Made of a bioactive glass, the granules are intended for filling bony voids and gaps. They can protect against microbial colonization as they are resorbed and replaced with bone during the healing process.

Clinical use of the S53P4 bioactive glass is supported by a 30-year history of research and more than 200 peer-reviewed publications, the company said.