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The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 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.

In addition, the Fortex 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).

Fortex rods are 5.5 mm diameter solid cylinders with spherically rounded ends, provided in 40 mm, 60 mm, 70 mm, 80 mm, 120 mm, 120 mm, 160 mm, 180 mm, 200 mm, and 300 mm lengths.

Each Fortex pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Selftapping pedicle screw assemblies are provided in diameters of 4.75mm, 5.5 mm, 6.5 mm, 7.5 mm and 8.25mm. All screw assemblies are provided in lengths of 30 mm, 35 mm, 45 mm, 50 mm, and 55 mm. Screws are provided in canulated and non-canulated configurations.

The Fortex cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.

The rods, pedicle screws and cross bars of the Fortex Pedicle Screw System are made of titanium alloy conforming to ASTM F136.

The provided text is a 510(k) summary for a medical device (Fortex Pedicle Screw System) which is a premarket notification to the FDA. It does not include information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing indications for use and technological characteristics, and typically relies on non-clinical (e.g., mechanical) testing rather than clinical studies with human subjects.

Therefore, I cannot fulfill your request for information about acceptance criteria and associated study details based on the provided text. The document does not contain this kind of data.

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