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The TowerLOX Spinal System is a posterior, noncervical 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.

In addition, when used as a pedicle screw fixation system, the TowerLOX Spinal 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), who are having the device removed after the attainment of a solid fusion.

The TowerLOX Pedicle Screw System is an implant device made from a titanium alloy TI 6AL4V-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, as either straight rods available in lengths from 30-500mm or pre-curved rods available in lengths from 30-120mm. The system includes a set screw, tulip heads, and a cap to complete the assembly of the implant. The system also includes all necessary instrumentation for a minimally invasive surgical technique

The TowerLOX Pedicle Screw System is a medical device. The 510(k) summary (K122332) indicates that this Special 510(k) involved changes that did not alter the mechanical function of the system; so no additional performance testing was conducted.

Therefore, the document does not contain information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as this information was not deemed necessary due to the nature of the submission (changes not impacting mechanical function).

The primary "acceptance criterion" for this submission was demonstrating that the modified device is Substantially Equivalent to the predicate device, given that the changes did not introduce new risks or alter mechanical function. The study proving this was the comparison to predicate devices, where Captiva Spine concluded that the changes did not introduce any new risks, thus supporting the substantial equivalence claim.

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