Device Dossier

Ostene Bone Hemostasis Material - Bone wax, synthetic

Device Dossier for Ostene Bone Hemostasis Material - Bone wax, synthetic (Bone wax, synthetic, Class III, sponsor Baxter Healthcare). ARTG record,…

Intended purpose

OSTENE is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Functional description

OSTENE is a water-soluble surgical implant material, and it can be used for the control of bleeding from bone surfaces by functioning as a mechanical barrier. Ostene does not act biochemically. Ostene is wholly synthetic and contains no animal products. Ostene has a functional lifetime of 2-5 hours after application and is fully resorbed within 30 days.

TGA Public Summary