Degenerative disc disease is common, with around 40% experienced at least one degenerated disc by age 40. Credit: Tada Images / Shutterstock.com

SurGenTec has secured US Food and Drug Administration (FDA) clearance for ION-L, a lumbar facet fixation system for treating degenerative disc disease (DDD) patients who have not benefited from conservative care protocols.

Suitable for implantation in the lower back region (L3-S1) of the spine’s vertebra, ION-L is designed to fixate the lumbar via a minimally invasive procedure wherein the implant is placed bilaterally through a posterior surgical approach.

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FDA clearance for the system was supported by clinical evidence from an Institutional Review Board (IRB)-approved study evaluating its long-term surgical safety and efficacy. Radiographic outcomes of this study, which deliberately evaluated a high-risk real-world patient cohort to whom lumbar fusion is most difficult to successfully achieve, were independently reviewed by two radiologists to assess fusion outcome, with no adverse events reported.

SurGenTec’s CEO, Travis Greenhalgh, commented: “For decades, spinal fixation has relied on bulky hardware and invasive techniques. With ION-L, we have demonstrated that surgeons can achieve the same clinical goals through a less invasive, facet-based approach.”

DDD is extremely common, with the natural cushioning of the spine beginning to wear away in a large proportion of individuals aged 40 and above. Research indicates that 40% of adults over the age of 40 have at least one degenerated vertebral disc, with this figure rising in concurrence with age.

SurGenTec’s ION-L joins the Florida-based company’s existing ION product range, which also includes its ION 3D facet screws and ION-C cervical facet implant, an implantable screw used to stabilise the posterior cervical spine’s facet joints during spinal fusion procedures. In January 2026, ION-C received an expanded indication from the FDA for use in cervical pseudoarthrosis treatment.

Research indicates that cervical pseudoarthrosis, which results in nerve compression, pain and numbness in other areas of the body such as the arms and back, is the driving force behind 45%-56% of neck revision procedures.

According to GlobalData analysis, the spinal fusion market is growing at a CAGR of 2.3% and is projected to be worth around $17.4bn in 2034.