Device Dossier

Exabone Putty - Graft, bone, synthetic

Device Dossier for Exabone Putty - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor MDSS AU). ARTG record, intended purpose, GMDN…

Intended purpose

EXABONE® PUTTY is a synthetic bone graft intended to fill traumatically or surgically created bone defects that are not intrinsic to the stability of the bony structure.

Functional description

EXABONE® PUTTY is a resorbable granulated paste material composed by mass of 32% nanocrystalline hydroxyapatite 51.5% water and 16.5% HA/TCP granules (0.5 – 1.0mm). The HA/TCP granules are composed of 60% Hydroxyapatite and 40% tricalcium phosphate. The device remains as a soft paste and will perform as an osteoconductive scaffold for at least 12 months, following which the residual material will continue to slowly resorb as part of the natural remodelling process, within a period of 24 months

TGA Public Summary