OrthoNext Platform System

The OrthoNext Platform System is a web-based software tool that assists orthopedic surgeons in planning surgery and post-operative treatment. It allows users to import X-ray images, overlay Orthofix product templates on those images, perform measurements, and simulate treatment plans. The software does not treat patients directly but informs healthcare professionals' clinical decision-making; clinical judgment is required to use it properly.

The subject device is functionally identical to its predicate (K202519) in principle of operation, web-based architecture, supported operating systems (Windows, macOS), system requirements, and image input formats (.png, .jpg). The primary difference is tablet support (iPad with iPadOS 15.8 minimum) added to the subject device, along with updated browser versions. All core functionality—image import, measurement tools, template overlay, and surgical planning—remains unchanged.

The device was developed following ANSI AAMI IEC 62304:2006 + A1:2016 (Medical device software — Software life cycle processes). Software verification and validation testing followed FDA Guidance documents 'Content of Premarket Submissions for Device Software Functions' (June 2023) and 'General Principles of Software Validation' (January 2002). Usability testing referenced IEC 62366-1 (Medical devices—Application of usability engineering to medical devices).

The subject device performs identical functions to the predicate device with the same intended use (preoperative and postoperative orthopedic surgery planning), same patient population, and same operating principle. Technical differences are minor and non-material: tablet support and updated browser versions do not change safety or effectiveness because the software logic remains unchanged and operates through the same web portal regardless of platform. Performance data demonstrates equivalent measurement accuracy (0.1 mm linear, 0.05° angular error for anatomical axes), sensitivity (1 mm linear, 1° angular), and AI/ML algorithm performance (0.8 accuracy, precision 1.0 for magnification marker detection). Verification and validation testing confirms the design meets original requirements and user needs without raising new safety questions.