OTS Hip

JSON twin: https://www.healthaidb.com/software/ots-hip.json

Company Name

Ortoma

Product URL

https://ortoma.com/ots-hip/

Company URL

https://ortoma.com

Categories

• clinical Care
• diagnostic Support
• surgical Navigation
• surgical Care
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• surgical Planning
• post-surgical Care
• medical Device
• Clinical
• Diagnostic
• Orthopedic Surgery
• Medical Imaging
• Artificial Intelligence
• Preoperative Planning
• Intraoperative Navigation
• Postoperative Follow-up

Summary

OTS Hip is an AI-powered surgical system designed to enhance precision and efficiency in hip replacement surgeries.

Description

OTS Hip is an orthopedic surgical system developed by Ortoma AB, utilizing artificial intelligence to assist surgeons in preoperative planning and intraoperative navigation for hip replacement procedures. The system comprises two main components: OTS Hip Plan for 3D preoperative planning and OTS Hip Guide for intraoperative navigation. It integrates CT and X-ray imaging data to create a personalized 3D model of the patient's anatomy, guiding surgical instrument and prosthetic placement in real-time to improve accuracy and safety during total hip arthroplasty. The system has received FDA 510(k) clearance in the United States and is marketed in Europe and Japan. In Japan, Ortoma has partnered with Johnson & Johnson K.K. for exclusive distribution rights. The system is designed to be easily integrated into existing surgical processes, aiming to provide better patient outcomes, fewer complications, and improved long-term survival rates for implants. OTS Hip is intended for use by orthopedic surgeons in hip replacement surgeries, with the goal of enhancing surgical precision and efficiency.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• IEC 62304
• IEC 62366
• ISO 14971
• ISO 9001
• ISO 14001
• ISO 27001
• ISO 45001

Company Founding

2007

Company Offices

• Sweden
• United States
• Japan

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• FDA 510(k)
• CE Mark
• ISO 13485
• IEC 62304
• IEC 62366

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR
• ICD-10
• SNOMED CT
• LOINC
• CPT
• NDC
• ICD-9
• HCPCS

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Preoperative planning
• Intraoperative navigation
• Postoperative follow-up
• 3D surgical planning
• AI-assisted implant positioning
• Real-time surgical guidance
• Patient-specific implant selection
• Surgical workflow integration
• Data analytics and reporting
• User-friendly interface

Id

SW0024

Integration Partners

Integrations

• DePuy Synthes implant systems
• Hospital information systems
• Electronic health records (EHR)
• Picture archiving and communication systems (PACS)
• Surgical navigation equipment
• Anesthesia monitoring systems
• Radiology imaging systems
• Laboratory information systems (LIS)
• Patient management software
• Billing and coding systems

Languages Supported

• English
• Japanese

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Custom implant design
• Advanced analytics
• Remote monitoring
• Patient engagement tools
• Surgical training modules

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data retention policies
• User data access controls
• Data portability
• Data erasure
• Privacy impact assessments
• Third-party audits

Product Code

SW0024

Product Name

OTS Hip

Ratings

Regions Available

• United States
• Europe
• Japan

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Firewall
• Intrusion detection system
• Data masking
• Access control lists

Specialties

• Orthopedic Surgery
• Hip Replacement
• Arthroplasty
• Surgical Navigation
• Medical Imaging
• Artificial Intelligence In Surgery

Support Channels

System Requirements

Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network connection

Target Users

• Orthopedic Surgeons
• Surgical Teams
• Medical Institutions
• Hospitals
• Clinics

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "OTS Hip",
  "company_name": "Ortoma",
  "product_url": "https://ortoma.com/ots-hip/",
  "company_url": "https://ortoma.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0024",
  "summary": "OTS Hip is an AI-powered surgical system designed to enhance precision and efficiency in hip replacement surgeries.",
  "description": "OTS Hip is an orthopedic surgical system developed by Ortoma AB, utilizing artificial intelligence to assist surgeons in preoperative planning and intraoperative navigation for hip replacement procedures. The system comprises two main components: OTS Hip Plan for 3D preoperative planning and OTS Hip Guide for intraoperative navigation. It integrates CT and X-ray imaging data to create a personalized 3D model of the patient's anatomy, guiding surgical instrument and prosthetic placement in real-time to improve accuracy and safety during total hip arthroplasty. The system has received FDA 510(k) clearance in the United States and is marketed in Europe and Japan. In Japan, Ortoma has partnered with Johnson & Johnson K.K. for exclusive distribution rights. The system is designed to be easily integrated into existing surgical processes, aiming to provide better patient outcomes, fewer complications, and improved long-term survival rates for implants. OTS Hip is intended for use by orthopedic surgeons in hip replacement surgeries, with the goal of enhancing surgical precision and efficiency.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "surgical Navigation",
    "surgical Care",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "surgical Planning",
    "post-surgical Care",
    "medical Device",
    "Clinical",
    "Diagnostic",
    "Surgical Navigation",
    "Orthopedic Surgery",
    "Medical Imaging",
    "Artificial Intelligence",
    "Preoperative Planning",
    "Intraoperative Navigation",
    "Postoperative Follow-up",
    "Medical Device"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Orthopedic Surgeons",
    "Surgical Teams",
    "Medical Institutions",
    "Hospitals",
    "Clinics"
  ],
  "specialties": [
    "Orthopedic Surgery",
    "Hip Replacement",
    "Arthroplasty",
    "Surgical Navigation",
    "Medical Imaging",
    "Artificial Intelligence In Surgery"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Japan"
  ],
  "languages_supported": [
    "English",
    "Japanese"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Sweden",
    "United States",
    "Japan"
  ],
  "company_founding": "2007",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Preoperative planning",
    "Intraoperative navigation",
    "Postoperative follow-up",
    "3D surgical planning",
    "AI-assisted implant positioning",
    "Real-time surgical guidance",
    "Patient-specific implant selection",
    "Surgical workflow integration",
    "Data analytics and reporting",
    "User-friendly interface"
  ],
  "optional_modules": [
    "Custom implant design",
    "Advanced analytics",
    "Remote monitoring",
    "Patient engagement tools",
    "Surgical training modules"
  ],
  "integrations": [
    "DePuy Synthes implant systems",
    "Hospital information systems",
    "Electronic health records (EHR)",
    "Picture archiving and communication systems (PACS)",
    "Surgical navigation equipment",
    "Anesthesia monitoring systems",
    "Radiology imaging systems",
    "Laboratory information systems (LIS)",
    "Patient management software",
    "Billing and coding systems"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "NDC",
    "ICD-9",
    "HCPCS"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network connection",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "IEC 62304",
    "IEC 62366"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "IEC 62304",
    "IEC 62366",
    "ISO 14971",
    "ISO 9001",
    "ISO 14001",
    "ISO 27001",
    "ISO 45001"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Firewall",
    "Intrusion detection system",
    "Data masking",
    "Access control lists"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data retention policies",
    "User data access controls",
    "Data portability",
    "Data erasure",
    "Privacy impact assessments",
    "Third-party audits"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0024",
  "slug": "ots-hip",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/ots-hip.json"
  }
}