JAZZ Spinal System

The JAZZ Spinal System is a posterior spinal fixation device consisting of titanium alloy or cobalt chrome screws and rods that are rigidly locked together in customized configurations. It is intended as an adjunct to fusion surgery for skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures, tumors, pseudarthrosis, or failed previous fusion, and has a specific indication for severe spondylolisthesis requiring removal after solid fusion is achieved.

The subject device adds new components and expanded size offerings to the previously cleared JAZZ Spinal System. Components include straight and pre-bent rods, monoaxial and polyaxial screws, reduction screws, domino connectors, crosslinks, dual-headed screws, transverse and sagittal uniplanar screws, favored angle screws, modular screws, iliac screws, and associated set screws, all made from titanium alloy, unalloyed titanium, or cobalt chrome alloy.

Performance testing was conducted per ASTM F1717-21 (static compression bending, static torsion, and dynamic compression bending) and ASTM F1798-13 (static neutral angle dissociation and static maximum angle dissociation).

The subject device has identical indications for use and materials to the primary predicate device (Implanet JAZZ Spinal System K240392) and similar design and characteristics to both predicates. Performance testing demonstrated equivalent mechanical performance to the predicate devices, and the addition of new component sizes and types does not raise new safety or effectiveness questions, supporting substantial equivalence.