Device Dossier
Exabone HA/TCP - Graft, bone, synthetic
Device Dossier for Exabone HA/TCP - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor MDSS AU). ARTG record, intended purpose, GMDN…
- GMDN category: Graft, bone, synthetic
Intended purpose
EXABONE® HA/TCP is a synthetic bone substitute intended to fill traumatically or surgically created bone defects that are not intrinsic to the stability of the bony structure.
Functional description
EXABONE® HA/TCP is a resorbable porous material in block form (including disc and wedge) and granular form, that is composed of nominally 60% (w/w) hydroxyapatite and 40% (w/w) β-tricalcium phosphate. The device 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 from implantation