Ion-C

The Ion-C is a bilateral facet joint implant system intended for temporary stabilization of the cervical spine (C3-C7) as an adjunct to anterior cervical fusion surgery in skeletally mature patients with anterior pseudoarthrosis. It is placed through a posterior surgical approach and spans the facet joint interspace, and must be used in combination with FDA-cleared anterior cervical plates and fusion devices.

The Ion-C and predicate PMT Facet Fixation System are both titanium implants intended for facet joint interspace placement for temporary stabilization during fusion. Key differences include: Ion-C is intended for 1-2 contiguous levels versus the predicate's single level use, and Ion-C is offered in both sterile and non-sterile formats while the predicate is sterile only. Both share zero-profile design with fenestrations for bone graft integration.

ISO 10993 (biocompatibility), ASTM F136 (titanium material specification), ASTM F1264 (static and dynamic three-point bend testing), ASTM F543 (axial pushout testing, torque to failure testing, insertion and removal torque testing), and retrospective clinical evaluation using dynamic radiographic and CT imaging.

The Ion-C demonstrates substantial equivalence to the PMT Facet Fixation System predicate through comparable safety and effectiveness profiles in the same patient population, as supported by retrospective clinical data and comprehensive performance testing. The technological characteristics do not raise different questions of safety and effectiveness, with both devices sharing the same intended purpose, material composition, and general design approach for facet joint stabilization.