SABER-C System

The SABER-C System is a cervical interbody fusion device intended for skeletally mature patients with degenerative disc disease of the cervical spine (C2-T1) at one or two adjacent levels. The spacer is filled with autograft or allogenic bone graft and used with supplemental fixation such as anterior cervical plates or posterior cervical screw fixation. The anterior cervical plate can also be used standalone with screws for various cervical spine indications including trauma, tumors, deformity, and spinal stenosis.

The SABER-C interbody devices are manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers per ASTM F2026, F136, F1295, and F560. The anterior cervical plate and fixation options (spikes or screws) are titanium alloy per ASTM F136 and F1295. The subject submission expands size offerings and includes minor design modifications to previously cleared devices.

Axial Screw Pullout and Insertion Torque testing per ASTM F543; plate pushoff testing. Materials specifications per ASTM F2026, F136, F1295, and F560.

The subject device has substantially similar indications, device sizing, geometry, technological characteristics, and materials as the predicate devices. Materials, manufacturing, sterilization, and packaging are identical to the primary predicate (SABER-C K190885), while device geometry and technological characteristics mirror the additional predicate (Hedron IC K191243). Performance testing demonstrates comparable mechanical properties, and the expanded size offerings and minor design modifications do not alter the fundamental function or safety profile relative to the predicates.