Food and Drug Administration authorization of spine surgery devices: a 2-decade analysis of clearance trends, regulatory pathways, and market entry

OBJECTIVE In this study, the authors aimed to characterize trends in the regulatory authorization of spine surgery devices in the United States, including device category composition, regulatory pathway use, decision timelines, and patterns of new market entry. METHODS Authorizations related to spine surgery issued between January 1, 2000, and December 31, 2023, were identified from the publicly available US Food and Drug Administration (FDA) 510(k), Premarket Approval (PMA), De Novo, and Humanitarian Device Exemption databases and classified into one of 7 categories (spinal implants and fixation, navigation, bone graft and augmentation, surgical instruments, neuromodulation and nerve, measurement and diagnostics, and other) according to intended use. Annual authorization volume, regulatory pathway, decision time, device class, sponsor experience, and manufacturer location were extracted, and category-level trends were evaluated using 3-year trailing averages. Group comparisons were performed using one-way ANOVA and Welch’s t-test. RESULTS A total of 5977 spine devices were authorized over the study period. Spinal implants and fixation accounted for most devices (n = 4328, 72.4%), followed by navigation (n = 753, 12.6%). Annual authorization volume more than doubled from 108 devices in 2000 to 342 in 2023. During the same period, the proportional share represented by spinal implants and fixation declined from 78.7% to 50.9%, while navigation increased from 0% to 31.3%, reaching 107 authorizations by 2023 and emerging as the second-largest spine category. The 510(k) pathway accounted for 99.4% of all authorizations. Special 510(k) submissions cleared faster than traditional submissions (59.1 vs 144.0 days), and Class III and PMA submissions required the longest review (530.0 and 613.8 days, respectively; all p < 0.001). Established sponsors and domestic manufacturers demonstrated shorter times to authorization than emerging and international counterparts (both p < 0.001). New market entries were concentrated in spinal implants and fixation (n = 1529) and bone graft and augmentation (n = 399). CONCLUSIONS The US spine device landscape has evolved from one dominated by implant and fixation hardware to a more diverse ecosystem defined by navigation, bone graft and augmentation, and other adjunctive technologies, which together now account for nearly half of annual FDA authorizations. Regulatory pathway, device class, sponsor experience, and manufacturer location were each associated with time to FDA decision. These findings provide spine surgeons, innovators, and regulators with a contemporary view of how spine technologies enter clinical practice and highlight areas that may warrant surveillance, particularly in incumbent-dominated categories.