Search Results

The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), or who are having the device removed after the attainment of a solid fusion.

The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and pre- lordosed configurations. The system includes set screws, pedicle screws, and rods along with the associated instrumentation to complete the procedure and implant construct.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (CapLOX II/TowerLOX Pedicle Screw System) and does not contain any information about acceptance criteria or a study proving that a device meets such criteria related to AI or software performance.

The document states:

• "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." This is a regulatory clearance based on equivalence to existing devices, not performance against specific acceptance criteria for a new type of study (like those you've inquired about).
• "Performance testing was not conducted as part of this submission." This explicitly indicates that the type of performance study you're asking for was not done for this particular submission. The changes being submitted are additions of new pedicle screw sizes and associated instruments, which do not represent a new worst-case for mechanical integrity and are within clinically accepted size ranges, thus not requiring new performance testing for substantial equivalence.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device