Primus Spinal Fixation System

The Primus Spinal Fixation System is a spinal implant assembly of screws, hooks, rods, and connectors used to immobilize and stabilize the spine in skeletally mature patients as an adjunct to fusion. It is indicated for thoracic, lumbar, and sacral spine procedures (T1-S1) to treat conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. The system supports anterior/anterolateral non-pedicle, posterior non-pedicle, and posterior pedicle fixation approaches.

The Primus Spinal Fixation System is identical or similar to the predicate Mercury II Spinal System with respect to intended use, device description, design, components, materials, principle of operation, manufacturing, labeling, sterility, and packaging. This 510(k) seeks clearance for minor modifications to the locking mechanism, component dimensions, and instrumentation while maintaining the same fundamental scientific technology.

Static and Dynamic Compression Bending Testing per ASTM F1717-21; Static Torsion Testing per ASTM F1717-21; Tensile Dissociation, Neutral and Max Angle Testing per ASTM F1798-21. Testing followed FDA Guidance for Industry and FDA Staff: Spinal System 510(k)s (May 2004).

The Primus demonstrates substantial equivalence because it has identical or similar intended use, indications for use, device description, technological characteristics, and performance to the predicate Mercury II Spinal System (K222516). The minor modifications to locking mechanism, component dimensions, and instrumentation do not alter the fundamental design principles or performance characteristics, as evidenced by mechanical testing that demonstrates equivalence to the predicate device.