Search Results

The Swedge™ Pedicle Screw Fixation 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis and failed previous fusion.

The Swedge™ Bezier rods may be used with compatible systems that use 4.75, 5.0, 5.5, and 6.0mm posterior rods made from either titanium alloy or cobalt chrome alloys. When connected to compatible systems, the Swedge™ Bezier rods are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis and/or kyphosis), spinal tumor, pseudoarthrosis, and failed previous fusion.

Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rod requirements.

The Swedge™ Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: DDD (degenerative disc disease) 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. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Swedge™ Pedicle Screw Fixation System is an implant device made from a titanium alloy (Ti-6Al-4VELI) and Cobalt Chrome. The subject device is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 4.5mm – 8.5mm and in lengths from 25mm – 120 mm. Titanium Alloy and Cobalt Chromium rods are available in 4.75mm – 6.0mm diameters either straight or pre-curved in lengths from 25-600 mm. Transition (Bezier) rods are also included with a tapered diameter from 4.75mm –6.0 mm and lengths of 60mm – 600mm. The system also includes locking set screws, cross-links connectors, standard, reduction and Long polyaxial tulip heads along with the associated instrumentation to complete the procedure and implant construct.

The purpose of this 510(k) submission is to modify the indications for use to include use of the Bezier rods with compatible pedicle screws of other pedicle screw systems beyond the Swedge™ system.

N/A

Ask a specific question about this device