FDA OKs SurGenTec’s ION-C Facet Fixation System

SurGenTec has gained U.S. Food and Drug Administration (FDA) clearance for its ION-C facet fixation system.

ION-C is part of the company’s posterior cervical platform and has received expanded indications to treat cervical pseudoarthrosis when implanted bilaterally within the facet joints. The clearance is supported by long-term clinical evidence from an Institutional Review Board (IRB)-approved study evaluating long-term surgical outcomes.

The facet fixation system was developed to address challenges associated with posterior cervical fusion. It incorporates design features intended to reduce incision size, mitigate intraoperative risk, and preserve native cervical alignment.

ION-C merges a zero-profile implant with a sterile, single-use instrumentation kit for controlled, non-impact insertion with in-situ depth adjustment.

Implant placement is performed using a controlled, non-impact insertion technique that eliminates the need for percussion, minimizing force on the cervical spine and protecting delicate anatomical structures. The system also enables in-situ implant depth adjustment during and after insertion.

A range of implant options supports neutral positioning, specifically designed to preserve native cervical alignment and lordosis. This approach allows fixation without forced distraction or segmental angulation, helping physicians avoid inducing kyphosis during posterior cervical fusion procedures.

“ION-C demonstrates our commitment to delivering cutting-edge solutions that empower physicians with advanced options to treat their patients,” said Travis Greenhalgh, CEO of SurGenTec. “Maintaining native alignment and curvature is critical in spine surgery. ION-C has demonstrated long-term fusion success while preserving the facet joints in a neutral position and minimizing the risk of joint expansion that can lead to postoperative kyphosis.”

In July 2025, the company’s OsteoFlo HydroFiber advanced synthetic bone graft earned an indication expansion from the FDA for use as a bone void filler to treat tumors, cysts, trauma, and osteomyelitis.