What To Know
- It 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 the removal of the implants after the attainment of a solid fusion.
- The 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.
Today Precision Spine, Inc. (a medical device company dedicated to Made-in-the-USA manufacturing) announced the launch of the Reform® MC (Midline Cortical) System, which utilizes a minimally disruptive approach designed to reduce muscle retraction laterally past the facet joint, and requires a smaller incision while maintaining direct visualization and access to the disc space.
The Reform MC system is a top-loading, multiple component, posterior spinal fixation system which consists of cannulated pedicle screws, straight and lordotic rods, and locking cap screws. Components are available in a variety of sizes to closely match patient anatomy.
“I have found that the Reform MC system’s medial to lateral trajectory, combined with its distinctive cortical cancellous screw thread design, helps achieve greater cortical bone purchase,” said Nicholas Renaldo, M.D. “Its modular screw design maximizes visualization and its low-profile, 4.75mm diameter cobalt chrome tulip helps conserve space without compromising strength.”
The Reform MC System is modular to enable intraoperative flexibility and confidence, featuring multiple size tulips, audible attachment, consistent assembly force, and a T25 drive feature. A tri-zone cortical-cancellous thread form with a stepped proximal diameter and an aggressive quick-start tip optimizes bone purchase during final seating. The system’s retractor delivers optimal access while minimizing muscle disruption, with 30° articulating arms and integrated dual fiber optics, and easy snap-on anatomically contoured, radiolucent blades in multiple length options increase procedure flexibility.
“The Reform MC System is an important step forward in the expansion of our Reform family of devices as we continue working with surgeons to design and commercialize advancements that combine versatility, efficiency, and cost-effectiveness,” said Chris DeNicola, Chief Operating Officer of Precision Spine.
The 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). It 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 the removal of the implants after the attainment of a solid fusion. The 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.
