SAGI Cervical Cage System

The SAGI Cervical Cage System is a stand-alone anterior cervical interbody fusion device for skeletally mature patients with degenerative disc disease and radicular symptoms at a single cervical level (C2-T1) who have failed six weeks of conservative treatment. It consists of a PEEK cage preassembled with a titanium alloy anterior fixation plate and screws, designed to be implanted via open anterior approach with autogenous bone graft to facilitate spinal fusion.

The device is composed of medical-grade PEEK-OPTIMA LT1 cage material, titanium alloy (Ti-6Al-4V) anterior fixation plate and screws, and tantalum radiopaque markers. Minor differences from predicates include variations in ZP-I and ZP-III interbody lordosis angles and marker material composition, available in multiple sizes to accommodate patient anatomy.

ASTM F2077-24 (torsion, axial compression, and compression-shear testing), ASTM F2276-24 (subsidence testing), ASTM F543-23 (pullout strength, driving torque, and torsional properties), ISO 11137-1:2015, ISO 11137-2:2013, and ISO 11137-3:2017 (sterilization validation via gamma radiation with SAL 10⁻⁶).

The SAGI Cervical Cage System is substantially equivalent to predicate devices (Stryker Spine AVS Anchor-C, Synthes Zero-P, and others) based on identical indications for use and substantially equivalent technological characteristics with only minor differences in lordosis angle and marker material that do not raise new safety or effectiveness questions. Non-clinical bench testing demonstrates performance equivalence to predicates.