Device Dossier

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

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

Intended purpose

MASTERGRAFT® Strips 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® Strips provides a bone void filler that is resorbed and is replaced with bone during the natural healing process.

Functional description

MASTERGRAFT® Strips are made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. The collagen is a highly purified Type I bioresorbable lyophilized collagen. MASTERGRAFT® Strips are supplied sterile in a premixed Strip form for single patient use. 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