SurGenTec, a medical device innovation company focused on advancing treatment options for orthopedic and spine surgery, 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.
Related: iotaMotion gains paediatric FDA indication for cochlear implant robot
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.
“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.”
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.
