OrthoNext Platform System

JSON twin: https://www.healthaidb.com/software/orthonext-platform-system.json

Company Name

Orthofix

Product URL

https://orthofix.com/products/spine-solutions/digital-healthcare/orthonext/

Company URL

https://orthofix.com/

Categories

• clinical Care
• surgical Planning
• surgical Care
• digital Health
• imaging Software
• Clinical
• Preoperative Planning
• Orthopedic Surgery
• Medical Imaging
• Orthopedic Procedures
• External Fixation
• Internal Fixation
• Osteotomy Planning

Summary

OrthoNext is a web-based application designed to assist healthcare professionals in preoperative planning for orthopedic surgeries by overlaying Orthofix product templates on radiological images and providing measurement and positioning tools.

Description

OrthoNext is a web-based application intended for preoperative planning of orthopedic surgery. The software allows for overlaying of Orthofix product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The platform is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. It enables image-based preoperative planning of orthopedic procedures using both external fixation and internal fixation, and includes simulation of osteotomy plan positioning based on scientific literature. The software also supports precise hardware device selection and positioning, and offers preoperative surgical plans available to replicate in the operating room, optimized inventory sent to the operating room, and appropriate instrument selection. Additionally, it provides accurate measurements, precise template selection and positioning, and a guided planning process with a simple user interface. The OrthoNext platform is not to be used for mammography. This medical device software may not be released for use in your region. Please refer to the list of countries where the medical device software is available for clinical use. By signing into the software, you confirm that you have carefully reviewed the list of countries, understand the regulatory status of this medical device software in your country, and are aware of the device usage limitations resulting from the regulatory status of this medical device software. Should you require any further clarification, please do not hesitate to contact your sales representative.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE Mark
• ISO 13485
• ISO 14971
• ISO 9001
• ISO 14001
• ISO 27001
• ISO 45001
• ISO 50001
• ISO 22301
• ISO 31000
• ISO 37001
• ISO 14064
• ISO 14065
• ISO 14066
• ISO 14067
• ISO 14068
• ISO 14069
• ISO 14070
• ISO 14071

Company Founding

1980

Company Offices

• United States
• Italy
• Other Countries as per Regulatory Approval

Compliance

• HIPAA
• FDA 510(k) clearance
• CE Mark
• ISO 13485
• ISO 14971
• ISO 9001
• ISO 14001
• ISO 27001
• ISO 45001
• ISO 50001
• ISO 22301
• ISO 31000
• ISO 37001
• ISO 14064
• ISO 14065
• ISO 14066
• ISO 14067
• ISO 14068
• ISO 14069
• ISO 14070
• ISO 14071

Customers

Data Residency

EU-only

Data Standards

• DICOM

Deployment Model

• SaaS

Features

• Preoperative planning for orthopedic surgery
• Overlaying Orthofix product templates on radiological images
• Measurement tools for image analysis
• Template positioning tools
• Simulation of osteotomy plan positioning
• Precise hardware device selection and positioning
• Preoperative surgical plan replication in operating room
• Optimized inventory management
• Appropriate instrument selection
• Digital planning for clinical case evaluation
• Guided planning process with simple user interface

Id

SW0113

Integration Partners

Integrations

• JuniOrtho Plating System
• TL-HEX TrueLok Hexapod System
• Fitbone Intramedullary Lengthening Nail
• Eight-Plate Guided Growth System

Languages Supported

• English
• Italian
• Other Languages as per Regulatory Approval

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• JPS Module
• Fitbone Module
• TL-HEX Module
• Mobile Patient Application

Os Platforms

• Web

Pricing Details

Contact vendor for pricing details.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0113

Product Name

OrthoNext Platform System

Ratings

Regions Available

• United States
• Europe
• Italy
• Other Countries as per Regulatory Approval

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2025

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Single Sign-On (SSO)
• Audit logs
• Two-Factor Authentication (2FA)

Specialties

• Orthopedic Surgery
• Pediatric Orthopedics
• Limb Reconstruction
• Deformity Correction
• Limb Lengthening
• Trauma Reconstruction
• Pediatric Limb Reconstruction
• Orthopedic Procedures
• External Fixation
• Internal Fixation
• Osteotomy Planning
• Orthopedic Imaging
• Surgical Planning
• Orthopedic Planning
• Orthopedic Templating
• Orthopedic Measurement
• Orthopedic Positioning
• Orthopedic Calibration
• Orthopedic Inventory Optimization
• Orthopedic Instrument Selection

Support Channels

System Requirements

Internet connection (56 Kbit/s), device capable of viewing PDF files, 50 MB disk space

Target Users

• Clinicians
• Surgeons
• Orthopedic Surgeons
• Medical Professionals
• Healthcare Professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "OrthoNext Platform System",
  "company_name": "Orthofix",
  "product_url": "https://orthofix.com/products/spine-solutions/digital-healthcare/orthonext/",
  "company_url": "https://orthofix.com/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0113",
  "summary": "OrthoNext is a web-based application designed to assist healthcare professionals in preoperative planning for orthopedic surgeries by overlaying Orthofix product templates on radiological images and providing measurement and positioning tools.",
  "description": "OrthoNext is a web-based application intended for preoperative planning of orthopedic surgery. The software allows for overlaying of Orthofix product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The platform is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. It enables image-based preoperative planning of orthopedic procedures using both external fixation and internal fixation, and includes simulation of osteotomy plan positioning based on scientific literature. The software also supports precise hardware device selection and positioning, and offers preoperative surgical plans available to replicate in the operating room, optimized inventory sent to the operating room, and appropriate instrument selection. Additionally, it provides accurate measurements, precise template selection and positioning, and a guided planning process with a simple user interface. The OrthoNext platform is not to be used for mammography. This medical device software may not be released for use in your region. Please refer to the list of countries where the medical device software is available for clinical use. By signing into the software, you confirm that you have carefully reviewed the list of countries, understand the regulatory status of this medical device software in your country, and are aware of the device usage limitations resulting from the regulatory status of this medical device software. Should you require any further clarification, please do not hesitate to contact your sales representative.",
  "categories": [
    "clinical Care",
    "surgical Planning",
    "surgical Care",
    "digital Health",
    "imaging Software",
    "Clinical",
    "Preoperative Planning",
    "Orthopedic Surgery",
    "Digital Health",
    "Medical Imaging",
    "Surgical Planning",
    "Orthopedic Procedures",
    "External Fixation",
    "Internal Fixation",
    "Osteotomy Planning"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Surgeons",
    "Orthopedic Surgeons",
    "Medical Professionals",
    "Healthcare Professionals"
  ],
  "specialties": [
    "Orthopedic Surgery",
    "Pediatric Orthopedics",
    "Limb Reconstruction",
    "Deformity Correction",
    "Limb Lengthening",
    "Trauma Reconstruction",
    "Pediatric Limb Reconstruction",
    "Orthopedic Procedures",
    "External Fixation",
    "Internal Fixation",
    "Osteotomy Planning",
    "Orthopedic Imaging",
    "Surgical Planning",
    "Orthopedic Planning",
    "Orthopedic Templating",
    "Orthopedic Measurement",
    "Orthopedic Positioning",
    "Orthopedic Calibration",
    "Orthopedic Inventory Optimization",
    "Orthopedic Instrument Selection"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Italy",
    "Other Countries as per Regulatory Approval"
  ],
  "languages_supported": [
    "English",
    "Italian",
    "Other Languages as per Regulatory Approval"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing details.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Italy",
    "Other Countries as per Regulatory Approval"
  ],
  "company_founding": "1980",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Preoperative planning for orthopedic surgery",
    "Overlaying Orthofix product templates on radiological images",
    "Measurement tools for image analysis",
    "Template positioning tools",
    "Simulation of osteotomy plan positioning",
    "Precise hardware device selection and positioning",
    "Preoperative surgical plan replication in operating room",
    "Optimized inventory management",
    "Appropriate instrument selection",
    "Digital planning for clinical case evaluation",
    "Guided planning process with simple user interface"
  ],
  "optional_modules": [
    "JPS Module",
    "Fitbone Module",
    "TL-HEX Module",
    "Mobile Patient Application"
  ],
  "integrations": [
    "JuniOrtho Plating System",
    "TL-HEX TrueLok Hexapod System",
    "Fitbone Intramedullary Lengthening Nail",
    "Eight-Plate Guided Growth System"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Internet connection (56 Kbit/s), device capable of viewing PDF files, 50 MB disk space",
  "compliance": [
    "HIPAA",
    "FDA 510(k) clearance",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 9001",
    "ISO 14001",
    "ISO 27001",
    "ISO 45001",
    "ISO 50001",
    "ISO 22301",
    "ISO 31000",
    "ISO 37001",
    "ISO 14064",
    "ISO 14065",
    "ISO 14066",
    "ISO 14067",
    "ISO 14068",
    "ISO 14069",
    "ISO 14070",
    "ISO 14071"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 9001",
    "ISO 14001",
    "ISO 27001",
    "ISO 45001",
    "ISO 50001",
    "ISO 22301",
    "ISO 31000",
    "ISO 37001",
    "ISO 14064",
    "ISO 14065",
    "ISO 14066",
    "ISO 14067",
    "ISO 14068",
    "ISO 14069",
    "ISO 14070",
    "ISO 14071"
  ],
  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Single Sign-On (SSO)",
    "Audit logs",
    "Two-Factor Authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "EU-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "2025",
  "integration_partners": [],
  "id": "SW0113",
  "slug": "orthonext-platform-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/orthonext-platform-system.json"
  }
}