Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched world wide the Reform® Ti Titanium 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 System features a titanium tulip and a triple lead thread to deliver strength, stability, and efficiency to all thoracolumbar constructs. A modified proximal tapered thread design increases bone screw interface, which enhances pull-out strength while reducing insertion torque. An aggressive self-starting tip on the Reform Ti screw combined with the system’s T25 drive feature, enables surgeons to achieve more immediate bone engagement, reliable insertion and maximum control during insertion. Hexalobular drive fittings on the bone screw and locking cap help reduce the incidence of toggle and stripping, and a square threaded locking cap geometry is designed to reduce the risk of cross-threading. A full complement of offset connectors, dominoes, hooks and cross connectors increases procedure flexibility.
“The system’s low-profile titanium tulip gives surgeons increased space for fusion,” said Vikram Udani M.D., “while decreasing the potential risk of adjacent segment facet impingement. The screw’s triple lead thread is extremely efficient and reduces the overall surgeon fatigue especially in longer constructs.”
“The Reform Ti System joins the rest of the Reform family of devices that bring advanced versatility, efficiency and cost-effectiveness to the OR,” said Chris DeNicola, Chief Operating Officer of Precision Spine.
The Reform 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.
Source: Company Press Release
