SurGenTec, a medical device company dedicated to advancing orthopedic and spine surgery solutions, has received clearance from the US Food and Drug Administration for its ION-C Facet Fixation System. The device is part of the company’s posterior cervical platform and now carries expanded indications that allow it to be used for treating cervical pseudoarthrosis when implanted bilaterally within the facet joints. The FDA decision is supported by long term clinical data generated from an Institutional Review Board approved study that evaluated surgical outcomes over an extended follow up period.
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The ION-C system was engineered to address persistent challenges faced during posterior cervical fusion procedures. Traditional techniques often require larger incisions and can place added stress on the cervical spine, increasing procedural risk. ION-C was designed with the goal of minimizing tissue disruption while maintaining natural spinal alignment. The system features a zero profile implant paired with a sterile, ready to use, single use instrumentation set. This design allows surgeons to perform controlled insertion without impact while also enabling precise depth adjustment during the procedure.
According to Travis Greenhalgh, Chief Executive Officer of SurGenTec, the FDA clearance reflects the company’s commitment to providing surgeons with practical and clinically validated tools. He explained that preserving the natural curvature and alignment of the cervical spine is essential for long term patient outcomes. Greenhalgh noted that clinical data show ION-C supports durable fusion while keeping the facet joints in a neutral position, which may reduce the likelihood of joint expansion and postoperative kyphosis.
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The clinical evidence supporting the clearance comes from a multicenter study conducted under IRB oversight. Patients were treated by both neurosurgeons and orthopedic spine surgeons, and outcomes were independently reviewed by a third party organization along with two radiologists. Long term imaging was used to assess fusion success and spinal motion. The results showed consistent bone bridging across the facet joints, with no reports of adverse events, implant movement, or the need for revision surgery. Imaging also confirmed that cervical alignment and lordosis were maintained following the procedures.
A key feature of the ION-C system is its controlled insertion method, which eliminates the need for hammering or percussion during placement. This non impact approach reduces force on the cervical spine and helps protect surrounding anatomical structures. Surgeons can also adjust implant depth in place, both during and after insertion. Multiple implant options are available to support neutral positioning, allowing fixation without forcing distraction or altering segmental angles. This design philosophy aims to reduce the risk of unintentionally inducing kyphosis during posterior cervical fusion.
In addition to its clinical benefits, the ION-C system is designed to support efficiency in the operating room. The kit includes sterile, single use instruments and pre sterilized implants, which simplifies surgical setup and reduces the need for instrument reprocessing. This streamlined workflow can help lower operational costs while also reducing infection risk, offering value to both surgical teams and healthcare facilities.
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