SurGenTec® has received FDA clearance for its ION-C™ Facet Fixation System, part of its posterior cervical platform.
The device can now be used to treat cervical pseudoarthrosis when implanted bilaterally in the facet joints, supported by long-term clinical data from an IRB-approved study.
ION-C™ is designed to reduce incision size, lower surgical risk, and preserve natural cervical alignment.
Its zero-profile implant and single-use, sterile instruments allow controlled, non-impact insertion with adjustable depth, helping maintain neutral spine positioning and preventing postoperative kyphosis.
Clinical results showed successful fusion, preserved cervical curvature, and no adverse events or implant migration.
The system also streamlines surgery with ready-to-use instruments, reducing reprocessing, costs, and infection risk. ION-C™ is now commercially available under its FDA-cleared indications.
