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THINK PORTFOLIO, NOT PRODUCT

Your patients’ needs define your product choice. Medtronic offers a variety of bone grafting options that support the level of activity required for the challenges of your patient, the site, and the procedure. 

Download the Medtronic biologics product brochure to see our entire portfolio.

GROWTH FACTORS

Infuse bone graft

Infuse™ Bone Graft

  • More than 18 years of clinical use
  • More than two million patients worldwide
  • Highly osteoinductive and provides a strong signal for bone formation

Indications, Safety, and Warnings

INFUSE PRODUCT INFO

ALLOGRAFT SOLUTIONS

Grafton demineralized bone matrix

Grafton™ DBM

  • Data — Over 80 peer‐reviewed clinical studies
  • Fibers — Exclusive fiber technology
  • Forms — 10 forms to meet surgical needs

Indications, Safety, and Warnings

GRAFTON PRODUCT INFO
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Magnifuse™ DBM

  • Most osteoinductive demineralized bone product
  • Patented resorbable mesh bag to provide containment
  • Unique handling

Indications, Safety, and Warnings

MAGNIFUSE PRODUCT INFO
Closeup of the FiberCel VBM.

FiberCel™ VBM

  • Human tissue allograft consisting of cryopreserved cancellous and conrticocancellous bone matrix that is asetically processed to preserve native factors that support bone repair
  • Healthier cells1‡
  • Fiber technology
  • Improved handling
FIBERCEL PRODUCT INFO

SYNTHETICS

Closeup of the Synthetics Mastergraft.

Mastergraft™ Family

  • Osteoconductive cell carrier- interconnected porosity mimics human cancellous bone providing scaffold for vascularization and new bone growth2,3
  • Controlled resorption- Unique biphasic composition (85% β-TCPand 15% HA) allows for bone formation to occur before the scaffold is resorbed4,5

Indications, Safety, and Warnings

MASTERGRAFT PRODUCT INFO
*

Restrictions and limitations apply.

Based on Pub-Med search 8/14/14 with keywords Grafton(TM), DBX and Osteosponge and Osteosponge.

Comparisons were made utilizing control samples that were produced using a process similar to existing cellular bone matrices. Samples for the comparison were obtained from identical sources.

1

Data on file. Animal testing not necessarily indicative of human clinical outcomes.

2

Zou. Preparation, microstructure and mechanical properties of porous titanium sintered by Ti fibres.

3

Boschetti. Design, fabrication, and characterization of a composite scaffold for bone tissue engineering. Int J Artificial Organs 31(8) 2008.

4

Yuan. Tissue responses of calcium phosphate cement; a study in dogs. Biomaterials 21 (2000).

5

Yamada. Osteoclastic resorption of calcium phosphate ceramics with different hydroxyapatite/β-tricalcium phosphate ratios. Biomaterials18 (1997) 1037-1041.

FIBERCEL™ VBM DESCRIPTION AND INTENDED USE

FiberCel™ is a human tissue allograft consisting of cryopreserved cancellous and corticocancellous bone matrix that is aseptically processed to preserve native factors that support bone repair.  FiberCel™ is a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271. Each allograft is restricted to homologous use for transplant in procedures for repair, replacement or reconstruction on a single occasion by a licensed physician or surgeon. FiberCel™ can be used in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.

Contraindications: The presence of infection at the transplant site is a contraindication for the use of this allograft.

INFUSE™  BONE GRAFT BRIEF SUMMARY

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.