COLONNADE Posterior Screw Fixation System

The COLONNADE Posterior Screw Fixation System is an internal fixation device for spinal surgery consisting of pedicle screws and rods made from titanium alloy. It is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients with indications including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.

The device has similar technological characteristics to predicate devices including design, intended use, material composition, function, and fundamental technologies. There are slight differences in the length and diameter of screws and rod length compared to predicates, but these do not affect the essential function or safety profile.

ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including static compression bending, static torsion, and dynamic compression bending tests.

The COLONNADE system is substantially equivalent because it shares the same intended use, indications for use, and fundamental technological characteristics as the predicate devices (Advanced LumFix Spinal Fixation System and LumFix Spinal Fixation System). Although there are slight dimensional differences in screw length, diameter, and rod length, the device demonstrates comparable mechanical performance through ASTM F1717 testing, and these variations do not alter the basic function, safety, or effectiveness of the fixation system.