GlassBone Granules

GlassBone Granules is a synthetic bone substitute made of bioactive glass (45S5 composition) intended to fill bone voids or gaps in the skeletal system (extremities and pelvis). It is used for defects resulting from benign bone cysts, tumors, surgical creation, or traumatic injury in patients 6 years and older, and gradually resorbs and is replaced with natural bone during healing.

GlassBone Granules is composed of the same bioactive glass chemistry (45S5 Bioglass with SiO₂, P₂O₅, CaO, and Na₂O) as the predicate BonAlive Granules, uses identical gamma sterilization at SAL 10⁻⁶, is single-use only, and shares the same mode of action through ion leaching. Differences are minor: GlassBone offers granule sizes of 0.5–1 mm and 1–3 mm (versus BonAlive's 0.5–0.8 mm and 1.0–2.0 mm) and product volumes of 0.5–16 cc (versus 1–10 cc), and both are brown in color (versus NovaBone's white), but these variations do not affect safety or effectiveness.

Bench testing followed FDA guidance on Resorbable Calcium Salt Bone Void Filler Devices and ASTM F1538. Biocompatibility was tested per ISO 10993-1 (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity, local implantation effects, genotoxicity). Sterilization validation and packaging used ISO 11137 and ISO 11607.

GlassBone Granules is substantially equivalent because it uses identical bioactive glass chemistry and sterilization method as the predicate BonAlive Granules, shares the same indications for use and principles of operation, and non-clinical bench and biocompatibility testing demonstrates comparable performance with no new safety concerns. The minor differences in granule sizes and product volumes are similar variations that do not affect safety or effectiveness. No clinical testing was required because the indications for use are equivalent to the predicate device.