Duet™ Spinal Fixation System

The Duet™ Spinal Fixation System is a dual-screw spinal fixation device made from titanium alloy (Ti-6Al-4V ELI) consisting of a halo-screw, sphere screw, and set screw. It is intended to immobilize and stabilize a single spinal segment in skeletally mature patients as an adjunct to fusion for treating degenerative disk disease, spinal stenosis, pseudoarthrosis, and failed previous fusion in the lumbar and sacral spine (L1-S1).

The subject and predicate devices have nearly identical technological characteristics: identical indications for use, identical materials of manufacture (Ti-6Al-4V ELI), and identical structural support mechanism. Minor differences in device components do not raise new safety or effectiveness concerns. The system offers similar surgical approach and screw size offerings as predicate devices.

Static and dynamic compression bending testing per ASTM F1717; static torsion testing per ASTM F1717.

The Duet™ system is substantially equivalent to the predicate Trivergent Spinal Fixation System (K201427) because it shares identical indications for use, materials of manufacture, structural support mechanism, surgical approach, and screw size offerings. Mechanical bench testing demonstrates that the Duet's strength is sufficient for its intended use and comparable to legally marketed predicate devices.