SMART Bun-Yo-Matic CT
Overview
SMART Bun-Yo-Matic CT (developed by Disior Ltd., a subsidiary of Paragon 28, Inc.) is an AI-driven, cloud-based medical image processing software designed for preoperative planning and diagnosis of foot and ankle deformities, specifically hallux valgus (bunions).
The software is built for orthopaedic surgeons, podiatrists, and radiologists operating in hospital and clinical environments. It processes three-dimensional Computed Tomography (CT) imaging data to generate precise anatomical measurements and patient-specific surgical plans.
Workflow Integration & Capabilities:
- Cloud-Based Portal: Operating as a web application, the software integrates directly into the SMART28 Case Management Portal, allowing clinicians to upload DICOM-compliant CT scans from any compatible web browser without dedicated hardware.
- Automated 3D Analysis: The system utilizes automated image analysis to calculate precise joint angles and rotational parameters, moving beyond traditional 2D slice evaluations to assess deformities in three dimensions.
- Surgical Planning: Clinicians can review automated measurements, adjust planning values, and generate tailored surgical plans. The software is specifically designed to provide parameters compatible with the Paragon 28 Bun-Yo-Matic Lapidus Clamp System.
- Secure Case Management: Features a secure interface for downloading case reports, tracking patient-specific plans, and collaborating on surgical cases.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Upload X-ray or WBCT to generate a 3D patient-specific case report in under 10 minutes.
- Powerful 3D Preoperative Planning.
- Allows for 3D Analysis From 2D X-Rays.
- Enhances the Ability to Assess the 1st TMT Joint.
- Identifies the Recommended Correction for Hallux Valgus.
- Detects the Presence of Abnormal Anatomy.
- Automated analytics of radiographic angles, measurements, and reference points.
- Virtual planning of treatments in 3D with live bone alignment measures.
- Fast and accurate analysis (ICC > 0.96) under 5 minutes.
Use Cases
- Diagnosis of orthopedic healthcare conditions of the foot and ankle.
- Preoperative planning for Hallux Valgus (bunions) correction.
- Assessment of treatment outcomes.
- Patient-specific implant creation (general Disior capability).
- Analyzing trauma and malformations in the foot and ankle.
- Enhanced visualization for patient education and understanding of planned procedures.
What Physicians Need to Know
For orthopedic surgeons, SMART Bun-Yo-Matic offers a powerful tool for preoperative planning of bunion correction, enabling rapid generation of patient-specific 3D surgical plans from X-rays or WBCT scans. Leverage its AI-driven algorithms to identify optimal corrections and detect abnormal anatomy, and utilize the real-time adjustment capabilities to refine plans. This system enhances visualization and reproducibility when paired with the Bun-Yo-Matic Lapidus Clamp, streamlining the planning phase and potentially improving surgical outcomes.
SMART Bun-Yo-Matic is a key module within Paragon 28's SMART28 Case Management Portal, an ecosystem designed to improve foot and ankle treatments through AI and data analytics. It integrates by accepting DICOM imaging data from weight-bearing X-rays and CT scans, allowing for seamless transfer and processing within the portal for surgical planning.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Contact for pricing — Not publicly disclosed; enterprise-level software. |
| Deployment | Software, inputs DICOM from CT/WBCT scans; likely cloud-based or on-premise for hospital/clinic environments. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated SMART Bun-Yo-Matic CT software received FDA 510(k) clearance (K240642) on June 20, 2024. It is intended for orthopedic healthcare professionals to assist in the characterization of anatomical structures of the foot and ankle using three-dimensional mathematical modeling and radiographic measurements from WBCT devices for diagnostic and treatment planning purposes. |
| Integrations | |
| EHR | Not specified |
| Specialties | Orthopedics, Radiology |
What the Web Says
The SMART Bun-Yo-Matic CT is a software system developed by Paragon 28 that utilizes AI and 3D modeling for preoperative planning of bunion (hallux valgus) correction surgery. It allows surgeons to upload X-ray or weight-bearing CT (WBCT) scans to generate a patient-specific 3D case report within minutes, aiding in diagnosis and surgical planning. The system is designed to improve precision and outcomes in hallux valgus surgery by providing detailed anatomical analysis, identifying recommended corrections, and allowing real-time adjustments to the surgical plan.
Overall: PositiveStrengths
- Generates 3D patient-specific case reports from X-rays or WBCT in under 10 minutes.
- Enables powerful 3D preoperative planning for hallux valgus correction.
- Allows for 3D analysis even from 2D X-ray images.
- Enhances the ability to assess the first TMT joint.
- Identifies recommended correction for hallux valgus, including IMA and metatarsal de-rotation.
- Detects the presence of abnormal anatomy.
- Integrates with the Bun-Yo-Matic Lapidus Clamp for precise intraoperative execution and reproducibility.
- Aids in restoring three-dimensional alignment of the foot.
Limitations
- Potential for measurement or segmentation errors in cases with co-occurring conditions like osteoarthritis causing deformation of the 1st metatarsal head or severe medial displacement of sesamoids.
- Limited publicly available physician reviews outside of company-sponsored statements.
- No independent tech reviewer, Reddit, G2, or Capterra reviews found.
- The FDA clearance (K240642) is for automated radiological image processing software, not specifically for a surgical device.
Based on reviews from: Paragon 28, Orthopedic Design & Technology (ODT), Business Wire, Ortho Spine News, Medical Device Network, Innolitics (FDA 510(k) listings and AI/ML SaMD Ground Truthing guide), PubMed Central (Machine Learning-Enabled Medical Devices Authorized by the US Food Food and Drug Administration in 2024)
Last updated: 2026-07-18
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