Precision Spine has announced the US launch of the Reform MC (midline cortical) system, a top-loading, multiple component, posterior spinal fixation system which consists of cannulated pedicle screws, straight and lordotic rods, and locking cap screws.
The Reform MC system utilises a minimally disruptive approach designed to reduce muscle retraction laterally past the facet joint, and requires a smaller incision while maintaining direct visualisation and access to the disc space, Precision Spine said in a press release. Components are available in a variety of sizes to 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 (Poughkeepsie, USA). “Its modular screw design maximises visualisation 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, Precision Spine said.
A tri-zone cortical-cancellous thread form with a stepped proximal diameter and an aggressive quick-start tip optimises bone purchase during final seating, Precision Spine added in its press release. The system’s retractor delivers optimal access while minimising muscle disruption, with 30 degree articulating arms and integrated dual fibre 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 commercialise advancements that combine versatility, efficiency and cost-effectiveness,” said Chris DeNicola, chief operating officer of Precision Spine.
The system is intended to provide immobilisation and stabilisation 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 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 (fracture or dislocation); spinal stenosis; curvatures (scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.