Device Dossier
Exabone Paste - Graft, bone, synthetic
Device Dossier for Exabone Paste - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor MDSS AU). ARTG record, intended purpose, GMDN…
- GMDN category: Graft, bone, synthetic
Intended purpose
The device 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® PASTE is a paste material composed of nominally 38% (w/w) nanocrystalline hydroxyapatite in water. 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 from implantation