Demineralized bone matrix

Magnifuse™ bone graft

<p>Magnifuse™ bone graft is a mesh-contained allograft for filling bone voids, supporting fusion with osteoinductive and osteoconductive properties.</p>

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Indications, Safety, and WarningsIndicationsMagnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile saline in order to adjust the consistency and handling characteristics of the bone graft material. Magnifuse™ Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.Magnifuse™ II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Magnifuse™ II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.ContraindicationsThe following are contraindications for the use of Magnifuse™ DBM Bone Graft and Magnifuse™ II Bone Graft:

The presence of infection at the transplantation site.

Treatment of spinal insufficiency fractures.

CautionThis 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.PrecautionsExtensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Despite the viral inactivation and extensive tissue donor selection and qualifications process used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to Magnifuse™ or Magnifuse™ II Bone Graft must be reported promptly to Medtronic (i.e., spine, pelvis, and extremities). Adequate fixation should be used to stabilize the implant site during bone formation and healing in bony voids or gaps of the skeletal system.

Features

Built on the trusted Grafton™ fiber technology, Magnifuse™ DBM stands out for its high osteoinductivity^†, compression resistance, and graft containment, making it a powerful choice for surgeons seeking reliable fusion outcomes. Its moldable, self-contained design ensures precise placement and handling, while preserving the natural growth factors essential for bone healing.

High osteoinductivity

The DMIN™ process helps maintain the naturally occurring growth factors in the bone enabling improved in vivo bone formation as compared to other common competitive processing solutions.^†

88.9%
fusion rate
in a multi-center, retrospective study of posterolateral spinal fusions²

Carrier-free delivery

The PGA mesh bag enables carrier free delivery without compromising osteoinductivity.^†

Conforms to anatomy

Once hydrated, the graft becomes pliable, allowing it to adapt to irregular anatomical surfaces and resist migration. Magnifuse is also compression resistant, maintaining its structural integrity throughout the procedure.

Smart containment

The polyglycolic acid (PGA) mesh is designed to support graft containment and precise placement at the surgical site. It gradually resorbs, facilitating cellular infiltration and fluid exchange while maintaining graft integrity during early healing.

Preclinical performance

In a two level rat spinal fusion model, Magnifuse™ DBM achieved 100% fusion at 8 weeks.^† In a single-level rabbit posterolateral spine fusion study, Magnifuse™ II also showed 100% fusion at eight weeks.^†