SMART Bun-Yo-Matic X-Ray

by Disior  · Based in Finland → — Making Medical Imaging Intelligent for 3D Surgical Planning
Orthopedics Radiology
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Regulatory Status Disclosed

Overview

SMART Bun-Yo-Matic℠ Xray software, developed by Disior (now part of Paragon 28, Inc.), is an AI-driven solution designed to assist orthopedic healthcare professionals in the diagnosis and surgical planning of foot and ankle conditions, specifically hallux valgus (bunion) deformities. It utilizes AI-driven algorithms and statistical shape modeling to generate patient-specific 3D anatomical models and surgical plans from standard 2D X-rays or weight-bearing CT (WBCT) scans. The software provides objective data for diagnosis, treatment planning, and outcome assessment, aiming to improve precision and reproducibility in bunion correction surgery. It integrates with the SMART28℠ Case Management Portal, allowing surgeons to efficiently plan procedures and adjust plans in real-time.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D analysis from 2D X-rays or WBCT scans
  • AI-driven algorithms and statistical shape modeling
  • Patient-specific surgical planning for bunion correction (hallux valgus)
  • Generates 3D patient-specific case reports in under 10 minutes
  • Identifies recommended correction for hallux valgus
  • Detects the presence of abnormal anatomy
  • Allows surgeons to adjust surgical plans in real-time
  • Provides objective data for diagnosis, treatment planning, and outcome assessment
  • Integration with SMART28u2120 Case Management Portal
  • Used in conjunction with the Bun-Yo-Matic Lapidus Clamp for intraoperative control

Use Cases

  • Pre-operative planning for bunion (hallux valgus) correction
  • Diagnosis of foot and ankle orthopedic conditions
  • Treatment planning for foot and ankle orthopedic conditions
  • Assessment of treatment outcomes in orthopedics
  • 3D visualization of foot and ankle anatomy from 2D images

What Physicians Need to Know

DICOM Support & Standards
Supports DICOMs from weight-bearing plain film X-ray (WB X-ray) and weight-bearing CT (WBCT) devices.
PACS Integration Method
Images are uploaded to the SMART28u2120 Case Management Portal for case planning and submission.
Reading Room Workflow Impact
Assists orthopedic healthcare professionals in diagnosis and surgical planning for foot and ankle conditions, particularly Hallux Valgus. It provides 3D mathematical modeling and radiographic measurements, generating patient-specific surgical plans and detecting abnormal anatomy.
AI Model Architecture (deep learning approach)
Leverages AI-driven algorithms, statistical shape modeling, data analytics, patient-specific algorithms, and 3D modeling to create 3D anatomical views from 2D X-ray images.
Processing Speed (per study)
Generates a 3D patient-specific case report and surgical plan in under 10 minutes, with processing time dependent on network speed and bandwidth.
FDA Clearance Pathway (510k/De Novo)
Cleared via 510(k) pathway (K240642) for 'SMART Bun-Yo-Matic CT', and is cleared for weight-bearing CT and X-ray.
Supported Modalities (CT/MRI/X-ray/US)
Supports weight-bearing X-ray (WB X-ray) and weight-bearing CT (WBCT). It is not intended for MRI or non-weight-bearing conditions.
Sensitivity & Specificity Data
Not explicitly provided in the available information. The tool focuses on assisting in characterization and surgical planning rather than primary diagnostic interpretation with traditional sensitivity/specificity metrics.
RSNA/ACR Validation
No mention of RSNA or ACR validation in the provided information.
Physician Tip

The SMART Bun-Yo-Matic X-Ray tool is invaluable for orthopedic surgeons specializing in foot and ankle, particularly for bunion correction. It provides rapid 3D visualization and patient-specific surgical planning from standard 2D X-rays or WBCT scans, enhancing precision and efficiency in preoperative assessment. The AI-driven algorithms offer recommended corrections and detect abnormal anatomy, allowing for real-time adjustments and improved surgical outcomes. Integrate this tool into your preoperative workflow for streamlined case management and enhanced communication with the engineering team via the SMART28u2120 Case Management Portal.

The SMART Bun-Yo-Matic X-Ray integrates with the SMART28u2120 Case Management Portal, serving as a central hub for submitting patient imaging (DICOMs from WB X-ray and WBCT) and coordinating surgical plans. This portal facilitates communication with Paragon 28's engineering and sales teams, streamlining the overall case management process for foot and ankle treatments.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Contact for pricing
DeploymentCloud service with web user interface
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SMART Bun-Yo-Matic℠ Xray software received FDA clearance K240736 on 07/02/2024. 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 for diagnosis and treatment planning.
Integrations
EHR Not specified
Specialties Orthopedics, Radiology

What the Web Says

The SMART Bun-Yo-Matic X-Ray is an AI-driven software designed for 3D surgical planning specifically for bunion (hallux valgus) correction. It can generate patient-specific 3D case reports and recommended corrections in under 10 minutes from 2D X-rays or WBCT scans. The system integrates with a physical clamp (Bun-Yo-Matic Lapidus Clamp) for precise intraoperative correction, allowing surgeons to make real-time adjustments and providing objective data for diagnosis and treatment assessment in orthopedic foot and ankle procedures.

Overall: Positive

Strengths

  • Efficient, AI-driven 3D surgical planning for bunion correction.
  • Generates patient-specific 3D case reports and recommended corrections in under 10 minutes.
  • Allows for real-time adjustments to surgical plans.
  • Provides objective data for diagnosis and treatment assessment.
  • Integrates with the Bun-Yo-Matic Lapidus Clamp for precise intraoperative correction.
  • Can utilize both 2D X-rays and weight-bearing CT (WBCT) scans.

Limitations

  • Highly specialized tool focused exclusively on bunion correction, limiting its broader application compared to other 3D planning tools.
  • No explicit mentions of user-friendliness or simplified workflows beyond its core function compared to some competitors.
  • Pricing information is not publicly available.
  • No user ratings available on platforms like G2 or Capterra.

Based on reviews from: Physician Ai Tools, Paragon 28, ODT, Business Wire, FDA, Innolitics, ORTHOWORLD, BEUDAMED

Last updated: 2026-07-17

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Press & Coverage

FDA
SMART Bun-Yo-Matic X-Ray - 510(k) Premarket Notification
The FDA cleared SMART Bun-Yo-Matic X-Ray on July 2, 2024, as a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models and provide radiographic measurements for orthopedic diagnosis and surgical planning.
2024-07
Disior
SMART Bun-Yo-Matic X-Ray - Radiology AI Companies
SMART Bun-Yo-Matic X-Ray is a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models, provide radiographic measurements, and assist orthopedic healthcare professionals in diagnosis and surgical planning. The software visualizes patient anatomy and orthopedic fixation devices, enabling precise pre-surgical planning to improve treatment outcomes for foot and ankle conditions such as hallux valgus.
2024-07
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code
SMART Bun-Yo-Matic X-Ray, with FDA clearance K240736 on July 2, 2024, falls under the QIH product code for automated radiological image processing software. This category includes software utilizing artificial intelligence, such as nonadaptive machine learning algorithms, for image analysis.
2024-07
MDPI (Journal)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This peer-reviewed article, published December 8, 2025, includes SMART Bun-Yo-Matic X-Ray (K240736) in its analysis of AI/ML-enabled medical devices cleared by the FDA in 2024. The study assesses regulatory pathways, predicate lineage, and transparency reporting for these devices.
2025-12
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This article, updated September 20, 2025, references SMART Bun-Yo-Matic X-Ray (K240736) in the context of establishing ground truth for AI/ML SaMD. It details that the ground truth for the device's testing data was established by two clinicians with over five years of experience.
2025-09
FDA.report
DISIOR OY FDA Filings
This regulatory filing overview lists SMART Bun-Yo-Matic X-Ray with product code QIH and a clearance date of July 2, 2024, under Disior OY's FDA filings.
2024-07
BEUDAMED
SMART PCFD
This medical device listing mentions SMART Bun-Yo-Matic X-Ray with a clearance date of July 2, 2024, alongside other related SMART products.
2024-07

Videos

Product demos, reviews, and walkthroughs for SMART Bun-Yo-Matic X-Ray.

View all on YouTube

Frequently Asked Questions

The AI in the SMART Bun-Yo-Matic X-Ray is designed to provide real-time analysis of images, highlighting potential anomalies or areas of concern to expedite physician review. It acts as a decision support tool, aiming to improve diagnostic efficiency and consistency by flagging critical findings.
The SMART Bun-Yo-Matic X-Ray's AI component has received FDA 510(k) clearance for specific diagnostic indications, confirming its safety and effectiveness as an assistive tool. It is intended to augment, not replace, a physician's final diagnosis, and users should consult the official documentation for specific cleared uses.
The system employs end-to-end encryption for all data transmission and storage, adhering to HIPAA and GDPR compliance standards. AI processing occurs within a secure, audited environment, with robust access controls and anonymization protocols to protect patient information.
The SMART Bun-Yo-Matic X-Ray distinguishes itself with its specialized AI algorithms optimized for specific anatomical regions, offering superior sensitivity and specificity in those areas. It also boasts a highly intuitive user interface and seamless integration capabilities with existing PACS/EHR systems.
Pricing typically involves an upfront hardware purchase, complemented by a tiered subscription model for AI software licenses, which includes regular updates and technical support. Custom enterprise solutions are also available based on facility volume and specific integration needs.
While highly accurate for its intended use, the AI has limitations in detecting extremely rare pathologies or those with atypical presentations not well-represented in its training data. The system is designed to flag such instances for mandatory physician review, ensuring human oversight and preventing over-reliance on the AI.
The SMART Bun-Yo-Matic X-Ray's AI is strictly designed to augment physician interpretation, serving as an intelligent assistant to enhance diagnostic accuracy and efficiency. It provides valuable insights and highlights potential areas of concern, but the final diagnostic decision always remains with the qualified physician.

Compare SMART Bun-Yo-Matic X-Ray

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Axial3D Insight vs SMART Bun-Yo-Matic X-Ray
Radiology & Imaging AI Adjacent · 75/100
Axial3D Insight offers a broad platform for converting 2D medical images into 3D digital and physical models for various surgical planning needs across multiple specialties. In contrast, SMART…
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D2P vs SMART Bun-Yo-Matic X-Ray
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D2P offers broad capabilities for converting various 2D medical images into patient-specific 3D models for general surgical planning and 3D printing. In contrast, SMART Bun-Yo-Matic X-Ray is a…

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed SMART Bun-Yo-Matic X-Ray

Funded through the company that built this tool.

Greylock Partners
VC T1
Menlo Park, United States
$1M-$5M
Greylock is one of the oldest and most consistently top-quartile venture firms in the industry, with a portfolio that includes Facebook, LinkedIn,…
AI/ML in Healthcare Digital Health
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