The regulatory green light arrives after two randomized controlled trials involving nearly 600 American patients. Beyond domestic testing, the device carries a significant global track record, with over 80,000 units implanted worldwide. A 2023 study published in The European Spine Journal bolstered the approval case, showing that 85% of patients maintained spinal motion a full decade after their initial procedure.

Jerome Trividic, CEO of Geneva-based Spineart, described the milestone as a vital step for surgeons seeking to offer patients long-term mobility rather than the rigidity associated with spinal fusion. By entering the US market with a mature, evidence-based product, the company aims to challenge the limited number of existing disc replacement options currently available to domestic hospitals.