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.


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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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