OrthoNext Platform System
Orthofix SrlThe OrthoNext Platform System is a web-based software that helps healthcare professionals plan orthopedic surgeries and treatments by overlaying product templates on X-ray images and providing measurement and simulation tools. It assists in both preoperative and postoperative planning, enabling clinicians to make informed decisions by digitally visualizing and measuring treatment options.
Intended Use
Assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment by overlaying product templates on radiological images, allowing measurements and positioning of templates.
Technology
A web-based modular software system that imports X-ray images, displays 2D views, overlays orthopedic product templates, and provides measurement and surgical planning tools for orthopedic surgery and treatment planning. Also includes AI/ML algorithms for automatic magnification marker detection on X-rays.
Performance
Performance testing included accuracy validation of manual measurements (mean linear error ~0.1-0.4 mm, angular error ~0.05-0.06 degrees), and AI/ML magnification marker detection with precision=1, accuracy=0.8, recall=0.75. Software verification and validation followed IEC 62304 and FDA guidance with usability testing confirming safety and interface requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2024
4 months - 2
FDA Approval
12/19/2024
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