EVOL® ha – Hyper C Cervical Interbody Fusion System

The EVOL® ha - Hyper C Cervical Interbody Fusion System is a cervical interbody fusion device designed for anterior cervical spine surgery in skeletally mature patients with conditions such as disc disease, instability, trauma, deformity, myelopathy, stenosis, or failed previous fusion. The device is used with supplemental fixation and bone graft to facilitate spinal fusion at up to two contiguous levels from C2-T1.

The device is manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560 for fluoroscopic visualization. It features various footprint sizes and heights with a central window for bone graft, teeth on superior and inferior faces to resist migration, and lordodic angles. The differences from the predicate EVOL® ha - C include new size offerings that are potentially a worst case for mechanical testing compared to the predicate, but these differences do not limit strength or structural integrity.

ASTM F2077 (expulsion testing) and ASTM F560 (tantalum marker composition). The device is manufactured per ASTM F2026 for PEEK material specifications.

Substantial equivalence is demonstrated through comparison of FDA product code, indications for use, surgical approach, anatomical region, implant materials, product dimensions, mechanical performance, and technology. The subject device shares the same intended use, materials (PEEK with tantalum markers), operating principles, design features, and performance characteristics as the predicates. Testing using acceptable scientific methods evaluated the impact of size differences and confirmed these changes do not raise new safety or effectiveness concerns, establishing both safety and effectiveness equivalent to the predicate devices.