B-onic Platform: A Single-Center Clinical Evaluation of an Integrated FabLab Workflow for Patient-Specific Surgical Planning and XR-Based Validation.

Background: Digital surgery integrates advanced imaging, computational modeling, additive manufacturing, and intraoperative navigation technologies. Although widely explored, most platforms remain fragmented and lack regulatory cohesion. The B-onic Platform was conceived as a unified workflow that enables surgical planning, device personalization, and intraoperative navigation within a regulatory-compliant framework. Objective: This study aimed to present a comprehensive single-center clinical evaluation of the implementation of the B-onic Platform in a large single-center cohort, focusing on efficiency, patient safety, and surgeon-reported outcomes. Methods: A retrospective review of 308 consecutive surgical plans was performed at La Paz University Hospital (Madrid, Spain) between 2020 and 2024 and compared with institutional historical controls from 2018 to 2019. Procedures included maxillofacial surgery, traumatology, reconstructive surgery, and other specialties. The platform incorporated imaging-based CAD modeling, 3D-printed biomodels and guides, and immersive validation through the NavigatorPro XR module. Outcomes analyzed were preoperative planning time, operative duration, 30-day complication and rehospitalization rates, intraoperative blood loss, and surgeon-reported perception of anatomical understanding and intraoperative confidence. Results: Mean preoperative planning time was reduced by 34% (-42 h; 95% CI: -48 to -36 h; p < 0.01) compared with historical controls. Mean operative duration decreased from 226 ± 74 min to 181 ± 61 min (-45 min; 95% CI: -52 to -38 min; p < 0.001). The 30-day postoperative complication rate decreased from 12.9% to 10.7% (absolute reduction 2.2%; 95% CI: 0.2-4.1%; p = 0.037), while rehospitalization rates declined from 9.1% to 4.3% (p = 0.012). Mean length of hospital stay decreased from 6.8 ± 3.1 to 5.2 ± 2.3 days (p = 0.022), and intraoperative blood loss was reduced by 12-30% across specialties (p = 0.008). NavigatorPro XR halved validation time for guides and implants (71.8 ± 22.4 h vs. 35.6 ± 18.9 h; p < 0.001). Ninety-two percent of surveyed surgeons reported improved 3D anatomical understanding and enhanced intraoperative safety. Conclusions: The B-onic Platform has transitioned from a prototype to a consolidated system, integrated into routine practice with significant gains in efficiency, safety, and training value. These findings support the potential of the platform as a precision surgery model; however, further multicenter prospective studies are required to confirm scalability.