Instability of the craniocervical junction is a potentially life-threatening condition requiring surgical stabilization. Traditional occipital plate fixation carries risks of construct loosening and intracranial complications due to variable skull thickness, particularly after posterior fossa decompression where plate fixation is challenging. Occipital condyle screws (OCS) provide direct fixation into the occipital condyles (OCs). However, comprehensive outcome data remains sparse. This systematic review and meta-analysis evaluated anatomical parameters, technical aspects, and surgical outcomes of OCS fixation in craniocervical stabilization. Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, PubMed/MEDLINE, Embase, and Scopus were searched for studies reporting techniques and outcomes of occipitocervical fixation using OCS. Two reviewers independently extracted data, and study quality was assessed using the Newcastle-Ottawa Scale, when possible. Random-effects meta-analysis was performed. The primary endpoint was to characterize the technical aspects of craniocervical fixation using OCS and to ascertain its overall feasibility, defined by morphometric suitability, technical success rates, and complication rates. Thirty studies met inclusion: 12 cadaveric (618 specimens), 10 imaging (1,604 participants), and 8 surgical (284 patients). Morphometry consistently showed larger OC in male populations. Bicortical screw placement achieved 100% technical success. Standard 3.5-mm screws (18–24 mm) were commonly used. Recommended trajectories varied (sagittal with 18°–28° angulation; axial with 22°–37° angulation). No major symptomatic vascular or permanent neurological complications occurred. Meta-analytic data revealed significant differences in morphometric measurements of the OC and differences in the OCS length and angulation parameters. OCS fixation appears to be an anatomically feasible and technically promising fixation strategy in selected patients when anatomy and technique are carefully evaluated. Population-specific morphometric variability mandates individualized preoperative assessment. Future comparative studies should define long-term outcomes, fusion rates, and optimize region-specific surgical parameters.

This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success.