HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)

HEDRON™ Cervical Spacers are anterior cervical interbody fusion devices used to provide structural stability following discectomy in skeletally mature patients. The HEDRON C-MIS™ variant is an integrated device indicated for one or two cervical spine levels (C2-T1) in patients with cervical disc disease, instability, trauma, deformity, myelopathy, stenosis, and failed previous fusion. Devices may be used with or without screws and/or anchors and are filled with autograft bone, allogeneic bone graft, or FDA-cleared bone void fillers.

HEDRON™ Cervical Spacers share similar technological characteristics with predicate devices including overall design, intended use, titanium alloy material composition, function, and range of sizes. The devices are additively manufactured from titanium alloy powder, with mating screws and anchors also manufactured from titanium alloy.

Mechanical testing including static and dynamic compression, torsion, compression-shear, subsidence, and expulsion was conducted in accordance with FDA Guidance for Class II Intervertebral Fusion Devices (June 12, 2007), ASTM F2077, and ASTM F2267.

The HEDRON™ Cervical Spacers are substantially equivalent to predicate devices based on similar technological characteristics, performance, design, and intended use. Mechanical testing demonstrates performance comparable to predicates, and the devices maintain the same fundamental design and function across all variants.