Swedge™ Pedicle Screw Fixation System Bezier Rod

The Swedge™ Pedicle Screw Fixation System Bezier Rod is a spinal implant made from titanium alloy or cobalt chrome that provides immobilization and stabilization of thoracic, lumbar, and sacral spine segments in skeletally mature patients as an adjunct to fusion. The device consists of transition rods with tapered diameters (4.75–6.0 mm) that can be used alone with the Swedge™ system or compatibly with other pedicle screw systems meeting specified rod diameter requirements, for treatment of conditions including degenerative disc disease, spondylolisthesis, fracture, deformity, tumor, pseudoarthrosis, and failed previous fusion.

The subject and predicate devices have identical technological characteristics: same structure and function, materials of manufacture (titanium alloy and cobalt chrome), styles and sizes (rods 4.75–6.0 mm diameter, 60–600 mm length), sterilization methods, and biocompatibility. The modification in indicated use to include compatibility with other manufacturers' pedicle screw systems does not introduce new technological differences.

ASTM F1798 (Axial Grip and Torsion Grip testing) and ASTM F1717 (Dynamic Compression Bending testing). Testing was performed across a range of screw designs from different manufacturers to demonstrate mechanical compatibility.

The Swedge™ Bezier Rod is substantially equivalent to the predicate device (K230482, Swedge™ Pedicle Screw Fixation System) because both share identical technological characteristics, materials, sizes, sterilization, and biocompatibility. Non-clinical performance testing demonstrates that the Bezier rods maintain sufficient strength and performance when used with compatible external screw systems, and the expanded indication for use does not raise new safety or effectiveness concerns. The modification is purely an extension of compatible use rather than a fundamental design change.