OFIX MIS App
Orthofix US LLCThe OFIX MIS App is a mobile software application designed to help healthcare professionals view, store, and measure images to plan orthopedic surgeries, specifically for spinal implant procedures. It uses images captured via a mobile phone camera to assist in selecting the correct rod length for pedicle screw spinal systems, aiding surgeons in making precise implant placement decisions.
Intended Use
The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries, including measuring anatomical components for surgical implant placement.
Technology
The device uses mobile phone camera to capture 2D images of the surgical site and measures differences between known pedicle screw diameters to recommend rod length. It is a mobile app supplementing the use of calipers and provides implant selection feedback.
Performance
Software verification and validation testing were performed according to FDA guidance, demonstrating the App meets required specifications. Usability testing showed accuracy and usability in bench top and simulated use tests. Overall performance is comparable to predicate devices, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/30/2023
7 months - 2
FDA Approval
9/26/2023
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