Device 300423 Granules

Device 300423 Granules is a dry, porous, resorbable bone graft substitute made of synthetic calcium phosphate granules (alpha-tricalcium phosphate and hydroxyapatite) supplied sterile in 6 mL glass vials. It is indicated for filling bony voids or gaps in the skeletal system (spine, ilium, pelvis) caused by surgery or trauma, where it resorbs and is replaced by bone during healing. For posterolateral spine use, it must be combined with blood or autogenous bone marrow aspirate and autograft.

Device 300423 Granules is a dry, granular form comprised of alpha-TCP (79–93%) and hydroxyapatite (7–21%), supplied in two granule sizes (0.25–1 mm and 0.8–2 mm). The predicate Device 300397 Putty contains the same calcium phosphate granules but mixed with Type I and III porcine collagen (80/20 ratio) in putty form. Both are osteoconductive, resorbable, and sterilized by X-ray irradiation; differences are final composition and packaging (glass vial with rubber stopper versus other format).

ISO 11137 (sterilization validation), ISO 11607-1:2019 and ASTM F-series (packaging), ICH Q1A(R2) (stability), ISTA 3A (transport simulation), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, implantation, hemocompatibility), ISO 10993-3:2014 (genotoxicity), USP <151> (pyrogenicity), and ICH Q3D (elemental impurities).

Both devices share identical intended use (filling non-structural bony voids via osteoconduction and resorption), identical core material composition (alpha-TCP and hydroxyapatite), and identical sterilization method (X-ray irradiation). The primary differences—final device form (dry granules vs. putty) and packaging (glass vial vs. predicate packaging)—do not raise new safety or effectiveness questions because the granule composition and biological profile are the same. Performance testing in a rabbit spinal fusion model demonstrated substantially equivalent manual palpation, radiographic, and histological outcomes, and biocompatibility testing confirmed no new biological concerns from the packaging materials.