Device Dossier

Mastergraft Putty - Bone implant material, biological, animal-source

Device Dossier for Mastergraft Putty - Bone implant material, biological, animal-source (Bone matrix implant, animal-derived, bioabsorbable, Class III,…

Intended purpose

MASTERGRAFT® Putty is intended to help fill voids or gaps in bone, which may be surgically created osseous defects, or osseous defects caused by traumatic injury to the bone. MASTERGRAFT® Putty provides a bone void filler that is resorbed and is replaced with bone during the natural healing process. The putty when combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT Putty can be used with autograft as a bone extender. Specific indications for use include oral/maxillofacial augmentation or reconstruction.

Functional description

MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a mouldable form of bone void filler. MASTERGRAFT® products are biocompatible, osteoconductive, porous implants that allows for bony in growth across the graft site while resorbing at a rate consistent with bone healing.

TGA Public Summary