Bone Grafting (Spine and Orthopaedic) HEALTHCARE PROFESSIONALS

INFUSE BONE GRAFT

A premium product for autograft replacement.

Infuse™ Bone Graft is the premium product for autograft replacement* due to its high osteoinductivity. Infuse bone graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier (ACS). One of the functions of the protein is to stimulate natural bone formation. Infuse bone graft is osteoconductive and highly osteoinductive.

Indications, Safety, and Warnings

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GRAFTON DBM

The most utilized and scientifically studied DBM brand

Grafton™ demineralized bone matrix (DBM) is the most utilized and scientifically studied DBM brand.1 Our aseptic processing technology preserves the function of naturally occurring growth factors — yielding Grafton DBM’s osteoinductivity scores. Proprietary fiber technology offers enhanced osteoconductive scaffold.2

Indications, Safety, and Warnings

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MAGNIFUSE Bone Graft, MAGNIFUSE II Bone Graft

A human-derived product that is demineralized, leaving only the organic portion of bone

Magnifuse™ Bone Graft is a combination of aseptically processed DBM fibers and surface-demineralized chips, delivered in a resorbable mesh containment system. Magnifuse DBM bone graft substitute/bone void filler is osteoinductive and osteoconductive.

Magnifuse II Bone Graft is a human based allograft product that has been processed removing the mineral component leaving only the organic portion of bone.

Indications, Safety, and Warnings

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MASTERGRAFT FAMILY

Synthetic, osteoconductive, resorbable scaffolds support new bone formation while remodeling

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 and maintain the viability of the patient's own cells.3 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.

Indications, Safety, and Warnings

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AUTOGRAFT HARVESTING

Helps deliver viable, cellular-rich cancellous autograft bone

The Corex™ minimally invasive bone harvester and the Marrow Cellution™ bone marrow aspirate (BMA) and stem cell harvesting system, each are capable of delivering viable, autologous cells from various surgical sites.

Indications, Safety, and Warnings

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SPINAL INDICATIONS

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device
Infuse™ Bone Graft/Inter Fix™ Threaded Fusion Device
Infuse™ Bone Graft/Inter Fix™ RP Threaded Fusion Device
Infuse™ Bone Graft/Perimeter™ Interbody Fusion Device
Infuse™ Bone Graft/Clydesdale™ Spinal System
Infuse™ Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
Infuse™ Bone Graft/Pivox™ Oblique Lateral Spinal System

The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level.

The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft:

  • The LT-Cage™ Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level.
  • The Inter Fix™ or Inter Fix™ RP Threaded Fusion Device, implanted via an anterior open approach at a single level.
  • The Perimeter™ Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1 or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1.
  • The Clydesdale™ Spinal System, implanted via an OLIF approach at a single level from L2-L5.
  • The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach at a single level from L5-S1.
  • The Pivox™ Oblique Lateral Spinal System implanted via an OLIF approach at a single-level from L2-L5.

The Infuse™ Bone Graft/Medtronic Interbody Fusion Device consists of two components containing three parts – a spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone. These components must be used as a system for the prescribed indication described above. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. The Infuse™ Bone Graft component must not be used without the Medtronic Interbody Fusion Device component.

NOTE: The Inter Fix™ Threaded Fusion Device and the Inter Fix™ RP Threaded Fusion Device may be used together to treat a spinal level. The LT-Cage™ Lumbar Tapered Fusion Device, the Perimeter™ Interbody Fusion Device, the Clydesdale™ Spinal System, the Divergence-L™ Anterior/Oblique Lumbar Fusion System, and the Pivox™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the Inter Fix™ OR Inter Fix™ RP implants to treat a spinal level.

The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone (PEEK).

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child- bearing potential should be advised to not become pregnant for one year following treatment with this device.

Please see the Infuse™ Bone Graft package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate Infuse™ Bone Graft kit. An electronic version of the package insert may be found at www.medtronic.com/manuals.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

TIBIA TRAUMA INDICATIONS

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE™ BONE GRAFT

Infuse Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. Infuse Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.

Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold for the bone morphogenetic protein solution and resulting bone. These components must be used as a system. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document.

Infuse Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with an active malignancy or patients undergoing treatment for a malignancy. Infuse Bone Graft should also not be used in patients who are skeletally immature, in patients with an inadequate neurovascular status, in patients with compartment syndrome of the affected limb, in pregnant women, or in patients with an active infection at the operative site.

There are no adequate and well controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

ORAL MAXILLIOFACIAL INDICATIONS

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTION FOR INFUSE™ BONE GRAFT FOR CERTAIN ORAL MAXILLOFACIAL AND DENTAL REGENERATIVE USES

Infuse Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.

The Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in the package insert.

Infuse Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy or patients undergoing treatment for a malignancy, in pregnant women, or patients with an active infection at the operative site.

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.

Infuse Bone Graft has not been studied in patients who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.

GRAFTON DBM: CONTRAINDICATIONS

The following are contraindications for the use of GRAFTON™ DBM and GRAFTON PLUS™ DBM: • The presence of infection at the transplantation site. • Treatment of spinal insufficiency fractures.

GRAFTON DBM: CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. GRAFTON PLUS™ DBM Paste contains starch. Therefore, caution should be exercised in using GRAFTON PLUS™ DBM Paste in a patient with a starch allergy and/or amylase deficiency.

For more details see Indications, Safety, and Warnings.

GRAFTON DBM DBF: CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin) and processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or processing solutions.

GRAFTON DBM DBF: CONTRAINDICATIONS

The presence of infection at the transplantation site is a contraindication for the use of this allograft.

For more details, see Indications, Safety, and Warnings.

MAGNIFUSE: CONTRAINDICATIONS

The following are contraindications for the use of Magnifuse™ DBM Bone Graft and Magnifuse™ II Bone Graft:

  • The presence of infection at the transplantation site.

MAGNIFUSE: CAUTION

This product may contain trace amounts of antibiotics (gentamicin), surfactant, and other solutions used in processing the bone tissue as well as the PGA mesh. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.

For more details see Indications, Safety, and Warnings.

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 Matrix, and MASTERGRAFT® Putty 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.

COREX: PRECAUTIONS

Once the trocar tip is removed, Corex’s trephine (hollow tube section) is not intended to further penetrate cortical bone. There are circumstances of use when cortical penetration might occur, or is even likely to occur. The surgeon must be keenly aware of this potential hazard, as serious or life-threatening injuries to nerves, vessels, or other soft tissue structures external to the bone’s cortical margins may result. The surgeon should understand the orientation and depth of penetration associated with the Corex cutting tip, relative to the skeletal anatomy within which it is being applied. Every effort to ensure that the cutting tip remains within the cancellous portion of the bone should be exercised. If there is any doubt, the device’s depth of entry and axial orientation should be measured and noted and, if appropriate, the device should immediately be withdrawn from the bone entry site.

Warning: Extreme caution should be utilized when placing the sharp tip of the device near vulnerable, “at risk” structures.

Warning: BE MINDFUL OF PENETRATION DEPTH WHEN DIRECTING HARVESTER TOWARD SCIATIC NOTCH. THE DISTAL ASPECT OF THE SECOND APPETURE IS 5CM FROM THE TIP OF THE TREPHINE.

For more details see Indications, Safety, and Warnings.

MARROW CELLUTION: Use only for bone marrow or autologous blood aspiration as determined by a licensed physician. The device is intended to be used by a physician familiar with the possible side effects, typical findings, limitations, indications and contraindications of bone marrow aspiration. The procedure should be performed on patients that are suitable for such procedure only.

MARROW CELLUTION CAUTION: For single patient use only. The design of this device may not perform as intended by the manufacturer if it is re-used. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device. After use, this product may be a potential biohazard. Handle in a manner, which will prevent accidental puncture. Dispose of in accordance with applicable laws and regulations. Carefully place the used needle in a sharps biohazard container after the procedure is completed.

For more details see Indications, Safety, and Warnings.


*

Approved for use in certain spinal, dental, and trauma indications


1

Based on Pub-Med search on 8/26/14 with key words Grafton, DBX and Osteosponge.

2

Martin GJ, Boden SD, Titus L, Scarborough NL New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthrodesis. Spine. 1999;24(7):637-645.

3

Kim et al, 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, 17:1515–1521