OFIX MIS App
Overview
The OFIX MIS App by Orthofix US is a mobile application designed for use by surgeons during spinal fixation procedures, specifically those employing percutaneous and mini-open approaches. It is compatible with iPhone X and newer models running iOS 15.0 and above.
The app assists in surgical workflow by allowing users to capture fluoroscopic images, calibrate them, and then perform measurements for rod length estimation. It provides a visual overlay of suggested rod sizes, which can be adjusted and rotated on the image. The app also enables the input of surgeon information and X-ray views, and it stores encrypted reports of previous uses, organized by surgeon name and date/time.
Key capabilities include:
- Image Capture and Calibration: Users can take pictures of fluoroscopic images and calibrate them using on-screen markers for accurate measurements.
- Measurement and Rod Overlay: The app facilitates measurement of anatomical structures and overlays suggested rod lengths, which can be manipulated on the screen.
- Report Management: It stores encrypted reports of past procedures, accessible within the app.
- Workflow Integration: The app integrates into the surgical workflow by providing tools for image analysis and implant sizing during minimally invasive spine procedures.
Access to the OFIX MIS App requires a valid email and passcode, typically for first-time use, and necessitates acceptance of terms and conditions.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- View and store medical images
- Measure images for surgical planning
- Plan orthopedic surgeries
- Assist in selecting rod lengths for pedicle screw spinal systems
- Capture 2D images via mobile device camera
- Measure differences between Orthofix pedicle screw diameters
- Provide feedback for appropriate rod length determination
- Mobile application for iPhone X and newer (iOS 15.0+)
- Calibration tools for precise measurements
- Encrypted reports of previous uses
Use Cases
- Pre-operative planning for spinal implant procedures
- Assisting in rod length selection for pedicle screw systems
- Measuring anatomical components for surgical implant placement
- Digital image management in orthopedic settings
What Physicians Need to Know
The OFIX MIS App is a specialized tool for orthopedic surgical planning, particularly for spinal procedures involving pedicle screws. It aids in precise measurement and templating using images captured via a mobile device camera. Physicians should use their clinical judgment and experience in conjunction with the app's measurements for optimal surgical outcomes. It is important to note that this app is not a diagnostic AI tool for interpreting radiology images for pathologies, but rather a planning and measurement aid for specific orthopedic procedures.
The OFIX MIS App is designed for compatibility with Orthofix's Phoenix System. Its image acquisition method relies on a mobile device camera, rather than direct integration with hospital PACS or DICOM systems for diagnostic image analysis. This suggests a workflow focused on standalone surgical planning specific to Orthofix products, rather than broad integration within a radiology department's imaging infrastructure.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Unknown |
| Deployment | Mobile application |
| Compliance | |
| BAA Available | No AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
1 AI-estimated The OFIX MIS App received 510(k) clearance (K230252) from the U.S. Food & Drug Administration on September 21, 2023. It is regulated under 21 CFR 892.2050 as a Medical Image Management Device and is indicated for assisting healthcare professionals in viewing, storing, and measuring images, and planning orthopedic surgeries by providing tools for measuring anatomical components for placement of surgical implants. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics |
What the Web Says
The OFIX MIS App, developed by Orthofix, is designed for orthopedic surgeons to assist with surgical planning, specifically for rod length and screw placement in spinal procedures. It is an iPhone-only application compatible with iPhone X and newer models running iOS 15.0 and above. The app allows users to capture X-ray images, calibrate measurements, and provides suggested rod lengths, aiming to improve precision in surgical outcomes.
Overall: MixedStrengths
- Assists with surgical planning for rod length and screw placement.
- Provides calibration tools for accurate measurements from X-ray images.
- Offers suggested rod lengths to aid surgeons.
- Encrypts reports for security.
- User-friendly interface for image capture and calibration.
- Can help differentiate between left and right implants in lateral X-rays with specific techniques.
Limitations
- Only available for iPhone X and newer models with iOS 15.0 and above.
- Requires specific permissions for camera access to function.
- Unsaved work is lost if the user navigates away from the current session.
- Requires careful attention to measured vs. suggested rod lengths.
- May be difficult to discern implant sides in lateral X-rays without specific techniques.
- No reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for the OFIX MIS App specifically, only for Orthofix as a company.
Based on reviews from: Rannkly, Orthofix, device.report, Indeed.com
Last updated: 2026-07-18
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