Bonalive Granules Gain Breakthrough Device Designation

By Julie A. Vetalice

Bonalive Granules Gain Breakthrough Device Designation

FDA has determined that Bonalive® Orthopedics granules, made of S53P4 bioactive glass, qualify for designation as a Breakthrough Device. Proposed indications include filling of bony voids and gaps, and potentially protecting against microbial colonization while the granules resorb and are replaced with bone during the healing process.

The clinical use of S53P4 bioactive glass is supported by a 30-year history of research and more than 200 peer reviewed publications. Bonalive products are available in the U.S., Europe, the Middle East, Asia-Pacific, Africa and South America.

"With antimicrobial resistance increasing worldwide, efforts are required to find new ways of coping with microbial infections. We are very pleased that our proposed indications for use meet FDA's criteria for designation as a Breakthrough Device," said Dr. Fredrik Ollila, Chairman and Founder of Bonalive Biomaterials Ltd.

Source: Bonalive Biomaterials Ltd.

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory