SABER-C System

The SABER-C System is a cervical intervertebral fusion device designed to provide structural stability in the spine following discectomy. It is used to treat degenerative disc disease of the cervical spine (C2-T1) in skeletally mature patients who have failed at least six weeks of non-operative treatment. The system includes intervertebral spacers (solid titanium and 3D printed porous titanium options) that can be filled with autograft or allogeneic bone, and an anterior cervical plate with fixation options using screws or spikes.

The SABER-C components are manufactured from titanium alloy per ASTM F136 or titanium-coated radiodense polyether ether ketone (PEEK) with tantalum markers per ASTM F2026, F136, F1295, and F560. The device is available in various geometric and material configurations. The subject submission adds additively manufactured components, expands size offerings, and includes minor design modifications to previously cleared devices. Materials, manufacturing, sterilization, and packaging are identical to the primary predicate.

Bench performance testing included Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Static and Dynamic Torsion per ASTM F2077, Expulsion, and Subsidence per ASTM F2267.

The subject device is substantially equivalent to the primary predicate (Elevation Spine SABER-C System, K250540) and additional predicate (Globus Medical Hedron IC, K191243) based on identical indications for use, similar device sizing, geometry, technological characteristics, and materials. Performance testing demonstrates comparable mechanical properties to predicate devices, and manufacturing and sterilization methods are identical to the primary predicate.