Device Dossier

Augment Bone Graft - Bone matrix implant, artificial

Device Dossier for Augment Bone Graft - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Stryker). ARTG record,…

Intended purpose

Augment Bone Graft is indicated for use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.

Functional description

Beta-tricalcium phosphate provides a highly porous resorbable and osteoconductive scaffold that provides a framework for bone ingrowth, aids in preventing soft tissue infiltration and promotes stabilization of the blood clot. It is mixed with Recombinant human platelet-derived growth factor BB (rhPDGF-BB), prior to implantation which stimulates the recruitment and proliferation of a variety of cell types, including bone cells and mesenchymal stem cells, while also promoting revascularization.

TGA Public Summary