Worldwide Launch of the Reform® Ti Modular Pedicle Screw System

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Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched worldwide the Reform® Ti Modular Pedicle Screw System, which provides surgeons with the increased flexibility, versatility, and visibility that is required during today’s challenging degenerative and trauma spine procedures.

The Reform® Ti Modular Pedicle Screw System provides surgeons with increased flexibility, versatility, and visibility to meet the varying requirements of degenerative and trauma procedures. The titanium tulips are available in standard and reduction options and feature a helpful audible click to confirm attachment. The titanium modular screws feature a minimally tapered, triple lead thread as well as a self-starting aggressive screw tip and enlarged T25 drive feature ─ the combination of which delivers more immediate, secure bone engagement and maximum control during insertion. A full complement of offset connectors, dominoes, hooks and cross connectors increases procedure flexibility.

“The system’s modular design greatly enhances O.R. versatility and efficiency,” said Vikram Udani, M.D., “assisting surgeons with intraoperatively assembling a construct that achieves immediate bone purchase, with a pull-out strength that provides optimal security.”

“The Reform Ti Modular Pedicle Screw System joins our Reform family of devices to bring surgeons even greater versatility, efficiency and cost-effectiveness to the demanding requirements of degenerative and trauma spine procedures,” said Chris DeNicola, Chief Operating Officer of Precision Spine.

The Reform Ti Modular Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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