Device Dossier

Nanostim Nano-Particular Hydroxyapatite Paste - Graft, bone, synthetic

Device Dossier for Nanostim Nano-Particular Hydroxyapatite Paste - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Medtronic). ARTG…

Intended purpose

NANOSTIM is a highly viscous, resorbable bone substitute for the filling of bone defects and bone graft extension in autogenous and allogenic cancellous bone transplantation. NANOSTIM is indicated for use in orthopaedics and traumatology to fill and reconstruct bone defects resulting, for example, from: fractures; resection of benign tumours or cysts; harvesting of autogenic grafts; to fill metaphyseal bone defects. NANOSTIM can be used as an extender for autogenic or allogenic bone grafts.

Functional description

Resorbable, nanocrystalline hydroxyaphatite bone grafting solution with osteoconductive properties that enhances new bone formation and stimulates bone healing. It is a non-hardening, calcium phosphate product set in a matrix of sterile water. The water based nature of this paste allows blood to easily integrate into the nanostructure of the material, which leads to faster vascularisation and cell migration.

TGA Public Summary