Device Dossier

Inductigraft - Bone matrix implant, synthetic

Device Dossier for Inductigraft - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Baxter Healthcare). ARTG record,…

Intended purpose

The Inductigraft bone graft substitute is indicated to be used in place of corticocancellous, or cancellous allograft or autograft bone in mechanical environments which experience either low load requirements or compression. • Surgical applications for the Inductigraft bone graft substitute are: - Spinal fusion, e.g. posterolateral spinal and interbody fusions, where appropriate hardware such as pedicle screws or an interbody cage device is used to relieve the graft site from physiological loads, • It is not indicated to be used in place of cortical strut allograft bone where high tensile, torsion and/or bending strength are required

Functional description

Inductigraft is silicate substituted calcium phosphate granules (1-2mm; 82.5% total porosity) in an aqueous carrier for use as a bone graft substitute. Inductigraft contains 0.8% silicon by weight, similar levels to those identified in naturally-growing bone. Inductigraft is 100% synthetic & does not contain any biological materials or natural proteins. After implantation, Inductigraft undergoes cell-mediated resorption & is replaced with bone as part of the patient’s own natural healing process

TGA Public Summary