Two Decades of Innovation: A Review of FDA Approvals for Spine Surgery Devices, 2000–2023

Introduction: The field of spine surgery has experienced transformative advances over the past two decades, yet the influence of regulatory pathways on the pace and nature of spine device approvals remains underexplored. This study investigates trends in FDA-approved spine devices, analyzing approval frequency, time to market, and the impact of regulatory classifications on clearance timelines.

Methods: We conducted a retrospective analysis of FDA-approved spine-related devices between 2000-2023. Devices were extracted from the FDA’s Neurology and Orthopedic Review Panels and classified. Devices were also stratified by company size (Emerging vs. Established). Approval times were calculated, and statistical comparisons across device classes and regulatory pathways were performed using ANOVA and t-tests.

Results: Between 2000 and 2023, the FDA approved 5,977 spine-related devices. Spinal Implants & Fixation dominated approvals (72.4%, n=4,328), followed by Navigation (12.6%, n=753). Substantial growth was observed in Bone Graft & Augmentation (+1,445%) and Spinal Implants & Fixation (+57.7%), while declines occurred in Measurement & Diagnostics (-50%) and Neuromodulation (-48.6%).

Approval times differed significantly across subspecialties (p < 0.01): Spinal Implants & Fixation were approved fastest (mean=115.0 days, SD=100.9), while Bone Graft & Augmentation took the longest (mean=151.1 days, SD=114.6). Class 3 devices required the most time (mean=530.0 days, SD=355.5), while Class 2 approvals were shorter (mean=119.6 days, SD=95.8). PMA devices faced the longest approval times (mean=613.8 days, SD=337.9) compared to 510(k) devices (mean=119.4 days, SD=94.8) (p < 0.01). Company size also impacted approval times; emerging companies ( < 5 devices) faced longer timelines (mean=151.7 days, SD=130.5) than established companies (mean=108.0 days, SD=85.6) (p < 0.01).

Conclusion : Our analysis underscores the complexities of bringing spine surgery devices to market, with regulatory pathways and company experience influencing approval times. Devices in stringent regulatory categories (PMA, HDE) experienced longer delays, while established companies navigated approvals more swiftly. These insights provide perspective on timeline-to-market and highlight areas to streamline regulatory processes, ultimately facilitating faster access to innovative spine technologies for patient care.