OrthoNext Platform System

by Orthofix Srl  · Based in Italy → — Preoperative planning of orthopedic surgery
Orthopedics

Contact for pricing
Regulatory Status Disclosed

Overview

The OrthoNext Platform System by Orthofix Srl is a digital preoperative planning and deformity analysis software designed for orthopedic surgeons, particularly those specializing in pediatric orthopedics, limb reconstruction, and deformity correction.

The platform integrates with Orthofix’s hardware portfolios, including the JuniOrtho Plating System, the Fitbone Intramedullary Lengthening Nail, and the TL-HEX TrueLok Hexapod System. It allows clinicians to perform manual linear and angular measurements on radiological images, overlay product templates, and simulate osteotomy positions to visualize implants in relation to patient anatomy before entering the operating room.

Key capabilities of the system include:

  • Deformity Analysis: Tools for mechanical axis analysis, contralateral leg comparison, and long leg planning.
  • AI-Powered Calibration: Automated identification and calibration of spherical markers on X-ray images to streamline image setup.
  • Surgical Simulation: Modules for simulating target positions, osteotomy levels, and blocking screw placements.
  • Workflow Integration: A unified calendar for scheduling strut events and adjustments, alongside tools to generate preoperative planning reports and optimized material lists to streamline operating room inventory.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Web-based application for surgical planning
  • Preoperative and postoperative orthopedic surgery planning
  • Overlaying Orthofix product templates on radiological images
  • Tools for measurements on images
  • Precise template positioning
  • Accurate calibration and templating
  • AI-Powered Automatic Marker Identification on X-rays (version 2.1)
  • Simulation of osteotomy plan positioning
  • Precise hardware device selection
  • Guided planning process and simple user interface

Use Cases

  • Preoperative planning for orthopedic surgery
  • Postoperative assessment and planning for orthopedic treatment
  • Deformity analysis and correction
  • Hardware device selection and positioning
  • Optimizing inventory for the operating room
  • Pediatric orthopedic planning

What Physicians Need to Know

FDA Clearance Pathway
510(k) cleared (e.g., K202519, K242270), categorized under Radiology for preoperative planning of orthopedic surgery.
Supported Modalities
Primarily X-ray images for orthopedic planning. Explicitly not for mammography.
AI Model Architecture
Features 'AI-Powered Automatic Marker Identification on X-rays' in version 2.1 for enhanced calibration in hexapod fixation planning.
DICOM Support & Standards
Requires anonymized X-ray images in JPG and PNG formats. Direct DICOM support is not explicitly mentioned.
PACS Integration Method
Web-based platform; no explicit PACS integration method is detailed, implying image upload rather than direct PACS connectivity.
Processing Speed (per study)
Not specified in available documentation.
RSNA/ACR Validation
No specific RSNA/ACR validation for the OrthoNext Platform System as an AI tool for image interpretation was found.
Physician Tip

OrthoNext Platform System is a valuable web-based tool for orthopedic surgeons, offering precise preoperative planning for procedures like bone lengthening and deformity correction. Leverage its capabilities for accurate calibration, measurements, and templating of Orthofix implants on X-ray images. The AI-powered automatic marker identification in version 2.1 can streamline the planning process, particularly for hexapod fixation cases. Remember that clinical judgment remains essential, as the software assists in planning rather than dictating surgical decisions. Utilize it to optimize hardware device selection and positioning, potentially leading to more streamlined surgeries and time savings in the operating room.

The OrthoNext Platform System is a web-based application. It supports the upload of anonymized X-ray images in JPG and PNG formats for planning. While direct DICOM and PACS integration methods are not explicitly detailed, its modular design allows for integration with various Orthofix product lines, including the JuniOrtho Plating System, Fitbone Intramedullary Lengthening Nail, and TL-HEX Hexapod System, providing a comprehensive planning solution for these specific orthopedic devices.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentCloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The OrthoNext Platform System received FDA 510(k) clearance (K242270) on December 19, 2024. It is classified as a Class II medical device under product code QIH (Automated Radiological Image Processing Software) and is intended for assisting healthcare professionals in preoperative and postoperative planning of orthopedic surgery.

Integrations
EHR Not specified
Specialties Orthopedics

What the Web Says

The OrthoNext Platform System by Orthofix is a web-based application designed for preoperative planning in orthopedic surgery, particularly for pediatric cases and deformity correction. It received FDA 510(k) clearance in May 2021 and has since seen updates, including version 2.1 which integrates AI and 3D visualization for enhanced precision. The system aims to assist healthcare professionals in planning implant positioning, streamlining device selection, and performing deformity analysis.

Overall: Positive

Strengths

  • Accurate calibration, measurements, and templating for pre-op planning and post-operative assessment.
  • Streamlines surgery and offers time-savings through pre-operative surgical plans and optimized inventory.
  • Provides image-based preoperative planning for both external and internal fixation procedures.
  • Offers a guided planning process and a simple user interface for ease of use.
  • Includes AI-powered automatic marker identification on X-rays for improved calibration.
  • Features 3D frame visualization in the post-operative phase for comprehensive views and decision-making.

Limitations

  • Limited public reviews available from independent sources like Reddit, G2, or Capterra specifically for OrthoNext Platform System.
  • Clinical judgment and experience are still required to properly use the software, indicating it's a tool to assist, not replace, professional expertise.
  • Information on pricing and potential integration challenges with existing healthcare IT systems is not readily available in the search results.
  • The most detailed reviews are from Orthofix itself or industry news releases, potentially lacking unbiased user perspectives.

Based on reviews from: Becker's Spine Review, Orthofix, Capterra

Last updated: 2026-07-20

Ratings & Reviews

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Press & Coverage

Orthofix
Innovating Orthopedic Deformity Correction with Advanced Pre-operative Planning
Orthofix's OrthoNext software version 2.1, released in April 2025, enhances hexapod fixator case planning with AI-powered automatic marker identification and a unified calendar for strut events. This update expands the platform's capabilities, which already included modules for Fitboneu2122 Intramedullary Lengthening Nail and JuniOrthou2122 Plating System planning.
2025-04
FDA
OrthoNext Platform System 510(k) Premarket Notification
A 510(k) Premarket Notification for the OrthoNext Platform System was submitted by Orthofix Srl, with a decision date of December 19, 2024. The system is intended for preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment.
2024-12
ODT Magazine
Extreme Fixes for Orthopedic Extremity Surgery
Published in March 2024, this article highlights the OrthoNext platform system's role in orthopedic extremity surgery by enabling surgeons to accurately plan osteotomy positions and visualize implants. The software streamlines device selection and optimal positioning before surgery.
2024-03
Business Wire
Orthofix Announces FDA Clearance of the OrthoNext Digital Platform for the JuniOrtho Plating System
Orthofix announced in May 2021 that it received FDA 510(k) clearance for the OrthoNext digital platform, specifically for use with the JuniOrtho Plating System. This platform is designed for deformity analysis and preoperative planning in pediatric orthopedic procedures.
2021-05

Videos

Product demos, reviews, and walkthroughs for OrthoNext Platform System.

View all on YouTube

Frequently Asked Questions

The OrthoNext Platform System, particularly with its version 2.1 update, utilizes AI for automatic marker identification on X-rays. This AI-powered feature helps to recognize and directly calibrate spherical markers, enhancing precision and efficiency in planning hexapod fixator cases.
For data privacy, X-ray images uploaded to OrthoNext must be anonymized, meaning they should not contain any information that directly or indirectly identifies a patient, such as name, birth date, or address. Access to the system is controlled by a username and password, and account activation requires validation of necessary user training.
While OrthoNext's AI assists in planning, it's crucial to remember that clinical judgment and experience are always required for proper use of the software. General limitations of AI in medicine include efficacy being dependent on training data, potential for false information from insufficient datasets, and varying performance based on data quality.
While several orthopedic EHR and practice management systems exist, some with AI-driven automation, direct alternatives specifically offering AI-powered preoperative planning with template overlay like OrthoNext are not explicitly detailed as direct competitors in the provided information. OrthoNext is noted for its unique capabilities in pediatric orthopedic planning.
Specific pricing details for the OrthoNext Platform System are not publicly available in the provided search results. Pricing for orthopedic software solutions can vary significantly, ranging from budget-friendly monthly subscriptions per provider to substantial annual costs for enterprise-level platforms.
The OrthoNext digital platform received U.S. FDA 510(k) clearance, indicating it has been reviewed for safety and effectiveness. The system is intended to assist healthcare professionals, and its user guide emphasizes that clinical judgment and experience are essential for proper use.

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