{"product_name":"Intelligent Surgery Knee","company_name":"Enhatch","product_url":"https://www.enhatch.com/intelligent-surgery-knee","company_url":"https://www.enhatch.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0275","summary":"Enhatch's Intelligent Surgery Knee is an AI-driven system that converts patient X-rays or CT images into detailed 3D models for personalized total knee arthroplasty planning, enhancing surgical precision and efficiency.","description":"Enhatch's Intelligent Surgery Knee utilizes advanced AI algorithms to transform patient X-rays or CT scans into detailed 3D anatomical models, facilitating personalized surgical planning for total knee arthroplasty. The system includes the FitCode™ Implant Recognition Engine, optimizing implant selection and positioning for the U2 Total Knee System by United Orthopedic. It operates on a cloud-integrated platform, streamlining data management and collaboration among surgical teams. The system has received FDA 510(k) clearance, ensuring compliance with medical device standards. By reducing reliance on traditional CT scans, it offers a safer and more cost-effective approach to preoperative planning, aiming to improve patient outcomes and surgical efficiency.","categories":["clinical Care","diagnostic Support","surgical Planning","imaging Software","Clinical","Diagnostic","Surgical Planning","Medical Imaging","Orthopedics"],"market_segment":["enterprise","smb"],"target_users":["orthopedic surgeons","surgical planners","medical device manufacturers","healthcare providers"],"specialties":["Orthopedics","Knee Surgery","Sports Medicine","Rehabilitation"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2019","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Advanced AI Algorithms for X-ray or CT segmentation","3D Anatomical Modeling for personalized surgical planning","FitCode™ Implant Recognition Engine for implant selection and positioning","Cloud-Integrated Platform for efficient data management","510(k) Cleared for patient-specific instrument design","Precision and Customization of surgical guides and plans"],"optional_modules":["Virtual Surgical Planning","Personalized Solutions","3D Printing by 3D Systems","Medical Device Surgical Case Plan"],"integrations":["United Orthopedic’s U2 Knee System","3D Systems Healthcare"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","HITECH","SOC 2 Type II","FDA 510(k) Clearance"],"certifications":["FDA 510(k) Clearance","SOC 2 Type II","HIPAA","HITECH"],"security_features":["Encryption","RBAC","Audit Logs","2FA"],"privacy_features":["BAA available","Consent Management","Anonymization","Data Minimization"],"data_residency":"US-only","customers":["United Orthopedic Group"],"user_reviews":["The AI-driven approach has significantly improved our surgical planning efficiency.","Integrating the Intelligent Surgery Knee system streamlined our preoperative processes.","The 3D anatomical modeling feature provides precise visualization for better surgical outcomes.","FitCode™ has optimized our implant selection, reducing time spent on planning.","The cloud-integrated platform allows seamless collaboration among surgical teams."],"ratings":["FDA 510(k) Cleared for Patient-Specific Instrumentation","AI-Powered Surgical Planning Solution","Advanced Imaging and 3D Modeling Capabilities","FitCode™ Implant Recognition Engine","Cloud-Based Data Management Platform"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2024","integration_partners":["3D Systems","United Orthopedic Group"],"id":"SW0275","slug":"intelligent-surgery-knee","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/intelligent-surgery-knee.json"}}