Device Dossier

AktiBone Granules - Graft, bone, synthetic

Device Dossier for AktiBone Granules - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Curatech). ARTG record, intended purpose, GMDN…

Intended purpose

Filling, reconstruction and/or fusion of bone defects or gaps in the skeletal system, in orthopedic surgery, spine, craniomaxillofacial, otorhinolaryngology surgery

Functional description

After implantation, the interstitial spaces between the granules allow fluid circulation and cellular and vascular colonization. The resorption of bioactive glass will allow the formation on the surface of a layer of carbonate hydroxyapatite, preventing graft rejection. This layer gives the granules their osteoconduction property. Following the carbonate hydroxyapatite layer reactions, bone growth continues, and bioactive glass continues to degrade and serves as a scaffold for bone regeneration.

TGA Public Summary