Hive™ Standalone Cervical System and Hive™ C Interbody System

The Hive™ Standalone Cervical System and Hive™ C Interbody System are spinal fusion devices made from titanium alloy. The Standalone system uses interbody fusion cages with screws or anchors for cervical spine fusion in skeletally mature patients with degenerative disc disease, instability, trauma, deformity, myelopathy, stenosis, or failed fusion. The Hive™ C system is an anterior cervical interbody fusion system with micro and nano-scale surface features for similar spinal fusion procedures, requiring supplemental fixation.

Both devices consist of additively manufactured titanium alloy (Ti-6Al-4V or Ti-6Al-4V ELI) interbody cages with various sizes and geometries. The Standalone system includes screws, plates, and anchors; the C system includes micro and nano-scale surface features on all cage surfaces. Key difference: the Standalone system offers anchors with a different diameter than the predicate, evaluated through cantilever bending testing per ASTM F2193 and shown substantially equivalent to predicate bone screws.

ASTM F3001 (titanium alloy specification), ASTM F136 (titanium alloy specification), ASTM F2077 (interbody fusion device mechanical testing including axial compression, shear, torsion), ASTM F2193 (cantilever bending testing for bone screws), ASTM F2267 (intervertebral body fusion device mechanical testing). Testing also included expulsion testing.

The subject devices are substantially equivalent to predicate devices because they share nearly identical technological characteristics, materials, sterility, sizes, integrated fixation methods, manufacturing, and biocompatibility. The minor difference in anchor diameter does not raise safety or efficacy concerns, as the new anchors were demonstrated through ASTM F2193 cantilever bending testing to be substantially equivalent to predicate bone screws. Mechanical performance testing confirms strength is sufficient for intended use.