SurGenTec® Secures FDA Clearance for ION-C™ Facet Fixation System — Designed to Support Fusion While Preserving Alignment

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec^®, a medical device innovation company focused on advancing treatment options for orthopedic and spine surgery, today announced FDA clearance of its ION-C Facet Fixation System. ION-C, part of SurGenTec^®’s posterior cervical platform, has received expanded indications allowing for the treatment of cervical pseudoarthrosis when implanted bilaterally within the facet joints. This clearance is supported by compelling long-term clinical evidence from an Institutional Review Board (IRB)–approved study evaluating long-term surgical outcomes.

Innovative Design Addressing Posterior Cervical Fusion Challenges

ION-C was developed to address well-known challenges associated with posterior cervical fusion. The system incorporates design features intended to reduce incision size, mitigate intraoperative risk, and preserve native cervical alignment. ION-C combines a zero-profile implant with a sterile, ready-to-use, single-use instrumentation kit, enabling controlled, non-impact insertion with in-situ depth adjustment.

Leadership Perspective on Clinical Impact

“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.”

IRB-Approved Study and Positive Surgical Outcomes

Patients were enrolled in a comprehensive, long-term, multicenter study approved by an Institutional Review Board (IRB). Procedures were performed by both neurosurgeons and orthopedic spine surgeons and were independently evaluated by a third-party organization and two radiologists to assess the safety and efficacy of ION-C when implanted bilaterally within the facet joints. Long-term imaging was used to evaluate fusion and segmental motion, with results demonstrating bridging bone across the facet joints and no reported adverse events, implant migration, or revision surgeries. Postoperative imaging further confirmed preservation of cervical alignment and lordosis.

Controlled, Non-Impact Insertion and In-Situ 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 ION-C 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.

Streamlined, Sterile Surgical Workflow

The ION-C kit includes sterile, single-use disposable instruments and sterile, ready-to-use implants, supporting standardized operating room workflows while reducing reprocessing time, cost, and the risk of infection.

Commercial Availability

ION-C expands SurGenTec^®’s spine portfolio and is now commercially available in accordance with its FDA-cleared indication.

About SurGenTec^®

SurGenTec^® develops innovative surgical technologies for spine and orthopedic procedures. The company is dedicated to advancing its product portfolio through internal development of solutions that address the evolving needs of healthcare providers and their patients. SurGenTec^® is committed to driving growth and supporting global surgical innovation, with recent expansion into international markets, including the launch of its new international sales headquarters in Brazil.

Contacts

SurGenTec Customer Service

(561) 990-7882

[email protected]