Ortho AI

by Ortho AI LLC
Neurosurgery Orthopedics Radiology
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Regulatory Status Disclosed

Overview

Ortho AI is a software as a medical device (SaMD) system designed to provide preoperative planning data for orthopedic surgeries. It specifically assists in total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery. The software utilizes AI/ML models to process x-ray images, enabling the measurement of lengths, angles, and the position of implants relative to bone structures. It allows for the overlaying of digital annotations on radiological images and includes tools for performing measurements based on these images and annotations. Ortho AI is intended for use by orthopedic surgeons and orthopaedic/neurosurgeons for preoperative and intraoperative planning, offering semi-automated templating and planning capabilities. It is not intended for primary image interpretation and is not for use on mobile phones.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Preoperative planning for total hip arthroplasty
  • Preoperative planning for total knee arthroplasty
  • Preoperative planning for lumbar spine fusion surgery
  • Assists in measuring lengths, angles, and implant positions from x-ray images
  • Allows overlaying digital annotations on radiological images
  • Software as a Medical Device (SaMD)
  • Utilizes AI/ML models for planning
  • Semi-automated templating/planning for surgery

Use Cases

  • Preoperative planning for total hip replacement surgery
  • Preoperative planning for partial/total knee replacement surgery
  • Preoperative planning for lumbar spine fusion surgery
  • Assisting orthopedic surgeons in precise surgical measurements from imaging

What Physicians Need to Know

DICOM Support & Standards
Ortho AI supports DICOM images, as well as standard image formats like .jpg and .bmp. It is designed to interact within the medical imaging ecosystem, implying adherence to DICOM interoperability standards for image input.
Reading Room Workflow Impact
Ortho AI is intended to assist in the measurement of X-ray images by measuring lengths, angles, and implant positions, and for overlaying digital annotations. It is not for primary image interpretation but serves as a tool for trained professionals (radiologists, orthopedists, physicians, medical technicians) to aid in clinical decision-making and reduce bias. This can streamline preoperative planning and potentially reduce the time burden of straightforward tasks.
AI Model Architecture
Ortho AI utilizes Deep Learning (DL) and Natural Language Processing (NLP) as core functions. DL is a subset of machine learning that mimics neural networks and is valuable for processing and analyzing vast amounts of data. It also incorporates a meticulously curated vector database developed by orthopedic surgeons.
Processing Speed (per study)
Specific processing speed per study for Ortho AI is not publicly detailed. However, AI-assisted interpretation of musculoskeletal radiographs has been shown to reduce reading time significantly, with some tools achieving millisecond-level inference times.
FDA Clearance Pathway
Ortho AI LLC received 510(k) clearance (K241696) from the FDA. This pathway is for devices substantially equivalent to a legally marketed predicate device.
Supported Modalities
Ortho AI is designed to work with preoperative radiographic images, specifically of the pelvis, knee, or spine. It supports X-ray images, including digitally computed (CR) or directly digital (DX) formats.
RSNA/ACR Validation
No specific RSNA/ACR validation studies or endorsements for Ortho AI were found. However, RSNA and ACR actively support the development and responsible integration of AI in radiology, emphasizing validation and transparency.
Physician Tip

Ortho AI is a valuable tool for enhancing precision in orthopedic measurements and surgical planning, particularly for the pelvis, knee, and spine. It acts as a decision support system, not a replacement for primary image interpretation. Physicians should leverage its semi-automated measurement and annotation capabilities to reduce bias and improve consistency in clinical judgment. Integrating it into existing workflows can streamline preoperative tasks, allowing more focus on complex diagnostic decision-making and patient care. Always remember that AI models are only as good as their data, so critical evaluation of the AI's output in the context of the full patient picture is essential.

Ortho AI's support for DICOM and common image formats (JPG, BMP) indicates straightforward integration potential with existing PACS and imaging modalities. For optimal workflow, ensure your PACS system is configured for efficient DICOM routing to the AI platform. While specific PACS integration details for Ortho AI are not provided, modern AI solutions often integrate via cloud-based, API-driven systems, offering scalability and secure data exchange. Collaboration with IT and vendors will be key to a seamless integration that minimizes disruption to current radiology and orthopedic workflows.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentSoftware as a Medical Device (SaMD), likely workstation/desktop based as it's not for mobile phones.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Ortho AI received FDA 510(k) clearance (K241696) on January 2, 2025, as a Class II medical device (Product Code: QIH, Medical image management and processing system). It is indicated to assist in making measurements for total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery from x-ray images.
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics, Radiology

What the Web Says

Ortho AI, also referred to as OrthoGPT or OrthoConsult.app, is an AI-powered tool designed for orthopedic surgeons, residents, and students, aiming to enhance clinical decision-making and streamline workflows. It provides evidence-based answers to complex orthopedic questions, drawing from peer-reviewed PubMed literature and specialized orthopedic datasets. The platform offers various features, including fast and evidence-based response modes, integrated PubMed search, and mobile accessibility.

Overall: Positive

Strengths

  • Provides evidence-based answers grounded in peer-reviewed literature and specialized datasets.
  • Offers fast and comprehensive responses to complex clinical questions.
  • Integrates PubMed search and links to relevant surgical videos.
  • Designed by orthopedic surgeons for orthopedic professionals.
  • Helps reduce administrative burden and improve efficiency in documentation and surgical planning.
  • Positive feedback from residents and attendings for guidance on complex cases and as a learning resource.

Limitations

  • Early versions sometimes fell back to vanilla GPT-4o, leading to answers without real citations.
  • Reference-checker only flagged missing citations, not fake ones, in earlier iterations.
  • Some AI tools in orthopedics have been described as unrefined and rushed, creating delays and inaccuracies.
  • Concerns exist about AI generating unrealistic patient expectations and confusion.
  • Potential for declining skills in the next generation of physicians due to over-reliance on AI.
  • Generalist AI training may have limited depth in MSK-specific terminology and require extra adjustment for orthopedic subspecialties.

Based on reviews from: Reddit, Capterra, Becker's Spine Review, Becker's Hospital Review, AIMD, Journal of Orthopaedic Case Reports, PubMed Central, Mass General Advances in Motion, Honey Health, DeepCura, MD Synergy, UCI Health, SPRY : Physical Therapy Software

Last updated: 2026-07-19

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Press & Coverage

Journal of Orthopaedic Case Reports / PMC - NIH
ORTHO AI : World's First ARTIFICIAL INTELLIGENCE IN ORTHOPAEDICS
This article introduces OrthoAI, described as the world's first AI focused on orthopaedics, launched in December 2023. It functions as a generative AI, similar to ChatGPT, designed to enhance clinical decision-making by providing evidence-based answers from a curated database, PubMed, and OrthoTV.
2023-12
Journal of Clinical Orthopaedics
ORTHO AI: The Dawn of a New Era: Artificial Intelligence in Orthopaedics
This editorial discusses the launch of OrthoAI in December 2023, highlighting its potential to revolutionize orthopaedics through improvements in diagnosis, treatment planning, surgical execution, prosthetics, rehabilitation, and predictive analytics. It also addresses the ethical and legal challenges associated with AI adoption in healthcare.
2023-12
Tech Funding News
France's DentalMonitoring secures $100M for Ortho AI u2014 TFN
DentalMonitoring, a Paris-based company, secured $100 million in funding in February 2026 to expand its AI-based remote monitoring platform globally, including applying its AI technology to other areas of dentistry beyond orthodontics. The investment aims to help orthodontic clinics manage more patients efficiently and reduce in-person visits.
2026-02
AIMD
OrthoAI u2014 Evidence-Based AI for Orthopaedics | AIMD
OrthoAI is presented as the world's first evidence-based generative AI for orthopaedics, acting as a 24x7 surgical companion. It provides answers to complex clinical questions, surgical techniques, and article reviews, grounded in peer-reviewed literature from PubMed and specialized orthopaedic datasets.
unknown
PMC - NIH
The AI Orthopedician will see you now u2013 But who is Liable if it's Wrong?
This article from February 2024 explores the role of AI in orthopedics, including systems like Ortho AI, and delves into the critical question of liability when AI systems fail and cause harm, particularly in India where regulations are unclear. It emphasizes the need for orthopedic surgeons to balance AI's benefits with their responsibilities as the legal framework evolves.
2024-02
FDA
K241696 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification from January 2025 details Ortho AI as a Software as a Medical Device (SaMD) system for preoperative planning in hip, knee, and lumbar spinal fusion surgeries. It utilizes AI/ML models to semi-automatically analyze X-ray images and place digital annotations.
2025-01
Digital Health
Privacy concerns raised over trust's AI data-sharing deal - Digital Health
A privacy campaign group raised concerns in August 2024 about a 2018 data-sharing agreement between the Royal National Orthopaedic Hospital (RNOH) and AI startup Naitive Technologies (formerly Ortho AI). The agreement covered the development of AI software for data analysis in orthopaedic surgery and musculoskeletal medicine, with concerns about adherence to NHS data sharing guidance.
2024-08
orthoi.ai
Ortho.iu00ae Advances Orthodontic Care with Innovative AI Multimodal Technology
In April 2024, Ortho.iu00ae announced advancements in orthodontic care with its AI multimodal technology, which analyzes dental images, simulates treatment outcomes, and customizes appliances. This technology aims to provide more productive treatments and improve patient quality of life.
2024-04

Videos

Product demos, reviews, and walkthroughs for Ortho AI.

View all on YouTube

Frequently Asked Questions

Ortho AI solutions are typically designed for seamless integration with existing systems like PACS and EHRs, often through APIs or dedicated software platforms. They can assist with tasks such as automated measurement of angles and distances, fracture detection, surgical planning, and predictive analytics for patient outcomes and perioperative risk.
Reputable Ortho AI solutions prioritize HIPAA compliance, implementing robust encryption, access controls, and de-identification techniques for patient data. Vendors should provide detailed documentation, often including Business Associate Agreements (BAAs), outlining their data handling protocols and security certifications.
Many Ortho AI tools, especially those used for diagnosis or treatment planning, require FDA clearance (e.g., 510(k)) or similar approvals from international regulatory bodies. The FDA is moving towards a Total Product Lifecycle (TPLC) approach, requiring continuous monitoring and validation for these evolving AI systems.
Alternatives include traditional manual measurements and interpretations by orthopedic specialists, alongside other non-AI digital tools. While human expertise remains crucial, Ortho AI often offers advantages in efficiency, consistency, and the ability to process large datasets, potentially reducing inter-observer variability for specific tasks.
Pricing models for Ortho AI commonly include subscription-based services, per-study fees, or tiered licensing based on user count or practice volume. Many vendors offer customized plans for different practice sizes, often with initial setup costs and ongoing support fees.
Limitations can include reliance on the quality and diversity of training data, potential for algorithmic bias, and the inability to account for all nuanced clinical contexts or unexpected surgical dilemmas. AI should be viewed as an adjunct, augmenting clinical judgment rather than replacing it, and its specific performance characteristics should be understood.
The accuracy of Ortho AI varies by application, with some solutions demonstrating performance comparable to, or even exceeding, human experts for specific tasks like fracture detection or implant identification. Clinical efficacy is supported by peer-reviewed studies, validation datasets, and real-world performance metrics, though some complex tasks still show human superiority.

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

Investors who backed Ortho AI

Funded through the company that built this tool.

Florida Funders
VC T3
Tampa, United States
$250k-$1M
Florida Funders is a Tampa-based venture firm and angel network with a thesis anchored in Florida-based founders and businesses, operating across seed…
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