Healthcare Professionals

Mastergraft Family of Products

Bone Grafting (Spine and Orthopaedic)

Overview

The Mastergraft® family of products are osteoconductive, resorbable scaffolds that may be used as bone graft substitutes and to extend autograft. Mastergraft products facilitate the delivery of the patient's own cells while maintaining their viability. The product portfolio provides  the Mastergraft technology as standalone granules, as a moldable/packable putty, and as a compression resistant and flexible strip. These synthetic bone grafts deliver a proprietary biphasic calcium phosphate (85% beta-tricalcium phosphate (B-TCP) and 15% hydroxyapatite (HA) in porous granules alone or in combination with bovine type I collagen. The biphasic chemistry and macro- and microporous structure is specifically engineered to balance new bone formation while remodeling into the patient's own bone.

Osteoconductive cell carrier and autograft extender

INDICATIONS: GRANULES (MIXABLE)

Mastergraft Granules are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, Mastergraft Granules and Mini Granules can be used with autograft as a synthetic bone graft extender. The granules are to be gently packed into bony voids or gaps of the skeletal system (e.g., 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.

Mastergraft Granules provide a bone void filler that resorbs and is replaced with bone during the healing process.


INDICATIONS: PUTTY (MOLDABLE/PACKABLE)

Mastergraft Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft bone 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 bone as a synthetic bone graft extender. The Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., 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 Mastergraft Putty resorbs and is replaced with bone during the healing process.


INDICATIONS: MATRIX EXT (COMPRESSION RESISTANT)

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 bone structure and can be used as a synthetic 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.


INDICATIONS: STRIP (FLEXIBLE)

Mastergraft Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a synthetic 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.


SUPPORTIVE DATA

  • Mastergraft synthetic bone graft can be hydrated with cell-rich bone marrow aspirate (BMA).
  • It can act as a carrier and deliver mesenchymal stem cells (MSCs) to the site.1
  • Histological evidence shows new bone formation came from transplanted cells vs. host cells.1
Cells are colonized throughout graft material

PRODUCT FEATURES: MASTERGRAFT GRANULES AND MINI GRANULES

Mastergraft granules are medical grade macro and microporous, resorbable ceramic granules.
  • Medical grade macro and microporous, resorbable ceramic granules
  • Each granule is composed of:
    • 15% hydroxyapatite (HA) , slow resorbing2
    • 85% beta-tricalcium phosphate (β-TCP)
      • Fast resorbing2
      • 80% interconnected porosity2
    • 500 µm average pore diameter2
    • 125 µm average interconnected diameter2
  • 85:15 ratio chosen due to:
    • Long-term stability2
    • Resorption rate2

Mastergraft granules are medical grade macro and microporous, resorbable ceramic granules.

PRODUCT FEATURES: MASTERGRAFT MATRIX EXT AND MASTERGRAFT STRIP

  • Resorbable osteoconductive cohesive scaffold
  • Composed of collagen mixed with Mastergraft Mini Granules
  • 96.5% ceramic and 3.5% bovine type 1 collagen2
  • Compression resistant

PRODUCT FEATURES: MASTERGRAFT PUTTY

Mastergraft granules are medical grade macro and microporous, resorbable ceramic granules.
  • Resorbable osteoconductive cohesive scaffold
  • Composed of collagen mixed with Mastergraft Mini Granules
    • 70% insoluble
    • 30% soluble Mastergraft Mini Granules
  • 80% ceramic and 20% bovine type collagen
  • Malleable and formable

MASTERGRAFT: CONTRAINDICATIONS

This product is not intended to provide structural support during the healing process; therefore, Mastergraft is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing relative contraindications include:

  • Severe neurological or vascular disease.
  • Uncontrolled diabetes.
  • Hypercalcemia.
  • Pregnancy.
  • Where stabilization of fracture is not possible.
  • Segmental defects without supplemental fixation.
  • Where there is significant vascular impairment proximal to the graft site.
  • When there are systemic and/or metabolic disorders that affect the bone or wound healing.
  • Any patient unwilling to follow postoperative instructions.
  • Any case not described in the indications.

Mastergraft Strip, Mastergraft Putty, and Mastergraft Matrix EXT should not be used in patients with a known history of hypersensitivity to bovine derived materials.


MASTERGRAFT: POTENTIAL ADVERSE EVENTS

A listing of potential adverse events includes, but is not limited to:

  • Deformity of the bone at the surgical site.
  • Fracture or extrusion of Mastergraft with or without generation of particulate debris.
  • Wound complications including hematoma, site damage, infection, bone fracture, and other complications common to any surgical procedure.
  • Incomplete, or lack of, osseous ingrowth into bone void, as possible with any bone filler.

For more details see Indications, Safety, and Warnings.


SMART STORAGE COMPATIBLE

An RFID-based, near real-time tissue tracking system

 

The Smartstorage™ System is an RFID-based, near real-time tissue tracking system that streamlines inventory management. No more worrying about manual recordkeeping — the Smartstorage System keeps accurate usage history and temperature logs. The system also notifies you when conditions need to be checked and assures precise accountability.


MANUALS AND TECHNICAL GUIDES

Find technical manuals in the product labeling supplied with each device or call Medtronic at 800-961-9055.


1

Kim Hyung-Jun. Transplanted xenogenic bone marrow stem cells survive and generate new bone formation in the posterolateral lumbar spine of non-immunosuppressed rabbits. Eur Spine J (2008).

2

Data on file.