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Globus launches newest addition to expandable spacer portfolio.

Audubon, Pa.-based Globus Medical Inc. has launched its new Fortify I, an expandable corpectomy spacer with integrated screws for further stability in addition to supplemental fixation. A corpectomy is a surgical procedure that involves removing part of the vertebral body usually as a way to decompress the spinal cord and nerves.

"The Fortify I integrated expandable corpectomy spacer and instrument system provides surgeons with an innovative device for trauma and tumor indications, said Andrew Iott, senior vice president of global product development. "This unique expandable technology allows for fixed and variable screw fixation through the endplates in a variety of minimally invasive surgical approach options from anterior to lateral, and adds new confidence in positional stability for the surgeon."

Fortify I adds to the Giobus portfolio of expandable spacers. The system provides anterior column support for individual and multiple level corpectomy patients, and uses integrated screws, superior and inferior, that are designed to prevent dislodgement. The spacer is available in a variety of sagittal profiles and footprints for an optimized fit, and has integrated titanium plates and screws for additional stabilization between the vertebral bodies and spacer. The radiolucent PEEK (polyetheretherketone) implant option is meant to allow for postoperative visualization and provide a modulus of elasticity closer to bone.

Fortify I integrated corpectomy spacers (Fortify I and Fortify I-R) are vertebral body replacement devices indicated by the U.S. Food and Drug Administration (FDA) for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine such as posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The system was granted 510(k) clearance from the FDA in June last year.

Globus Medical makes spinal implants.

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Title Annotation:New Technology Update; Fortify I
Publication:Orthopedic Design & Technology
Geographic Code:1USA
Date:May 1, 2013
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