Elegance® Anterior Cervical plate

The Elegance® Anterior Cervical plate is a titanium alloy cervical fixation system designed for anterior spinal fusion from C2 to C7. It is indicated for treating degenerative disc disease, spondylolisthesis, spinal stenosis, deformities, pseudoarthrosis, and revision surgery. The device consists of plates with bone screw holes and locking mechanisms, available in 1-5 level configurations with self-drilling or self-tapping screws that are inserted anteriorly into vertebral bodies.

The subject device and its predicate (Aggeris™-C, K220182) are nearly identical: both use ASTM F136 titanium alloy material, feature the same plate lengths and curvatures, and employ the same manufacturing process. Minor technological differences between the devices do not raise new safety or effectiveness issues.

Static Torsion Test (ASTM F1717), Axial Compression (ASTM F1717), and Dynamic Compression (ASTM F1717) were performed on the subject device to demonstrate its mechanical properties and stability.

The device achieves substantial equivalence because it shares identical intended use and indications with the predicate device, uses the same material and design specifications (plate lengths, curvatures, manufacturing), and demonstrates equivalent performance through standardized mechanical testing. The minor differences between the devices do not introduce new safety or effectiveness concerns, and testing shows the subject device performs at least as well as the cleared predicate.