Device Dossier

MASTERGRAFT Matrix EXT - Bone matrix implant, animal-derived, bioabsorbable

Device Dossier for MASTERGRAFT Matrix EXT - Bone matrix implant, animal-derived, bioabsorbable (Bone matrix implant, animal-derived, bioabsorbable, Class…

Intended purpose

MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium,and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Functional description

MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent β-tricalcium phosphate formulation. MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use.

TGA Public Summary