{"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"}}