United Orthopedic Knee Patient Specific Instrumentation

by Enhatch  · Based in United States → — Pioneering Intelligent Surgery for faster, safer, and smarter orthopedic procedures.
Orthopedics Radiology
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Regulatory Status Disclosed

Overview

The United Orthopedic Knee Patient Specific Instrumentation is an AI-powered system developed by Enhatch, designed to streamline preoperative planning for total knee arthroplasty (TKA). This cloud-based platform leverages advanced AI algorithms to convert 2D medical scans (X-rays or CT images) into detailed 3D anatomical models of a patient’s knee. It facilitates the design of patient-specific surgical guides and anatomical models, which are then used to assist in the precise positioning of compatible total knee arthroplasty systems, such as the U2 Total Knee System by United Orthopedic Corporation. The system aims to enhance surgical precision, reduce operating times, decrease blood loss, and improve adherence to the preoperative plan. It also includes features for customizable workflows, real-time collaboration among surgical teams, and an Implant Recognition Engine (FitCode™) for optimizing implant selection and positioning. Enhatch’s platform is entirely cloud-based, ensuring accessibility from any laptop or tablet, and integrates with 3D printing partners like 3D Systems for seamless manufacturing of patient-specific solutions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered 3D segmentation from X-ray or CT images
  • Customizable surgical planning workflows
  • Real-time collaboration tools for surgical teams
  • Design of patient-specific surgical guides and anatomical models
  • Cloud-based platform for remote access
  • Implant Recognition Engine (FitCodeu2122) for implant optimization
  • Integration with 3D printing partners for manufacturing
  • Executive dashboard for case management and tracking
  • Reduced radiation exposure with X-ray based 3D modeling
  • DICOM Viewer for patient data verification

Use Cases

  • Preoperative planning for total knee arthroplasty (TKA)
  • Design and manufacturing of patient-specific implants and instruments
  • Streamlining surgical workflows and increasing efficiency
  • Remote collaboration for surgeons, reps, and engineers
  • Enhanced surgical accuracy and adherence to surgical plans
  • Inventory management and logistics for medical devices

What Physicians Need to Know

Surgical Planning Capabilities
Leverages advanced AI algorithms for accurate X-ray or CT segmentation, creating detailed 3D anatomical models for personalized surgical planning. Includes FitCodeu2122 for optimizing implant selection and positioning specifically for United Orthopedic's U2 Knee System. The system is 510(k) cleared and reduces reliance on CT scans for TKA preoperative planning.
Intraoperative Guidance
Provides patient-specific surgical instruments (PSIs) and customized guides, fabricated based on the surgical plan, to precisely reference the placement of implant components intra-operatively. These single-use instruments are tailored to individual patient anatomy to assist in accurate incision placement, implant positioning, and bone correction.
3D Reconstruction Quality
Utilizes AI-driven segmentation to convert X-rays or CT scans into highly accurate and detailed 3D anatomical models of the knee. A special marker on X-rays provides a consistent reference frame, enhancing the accuracy and reliability of the 3D reconstruction process.
Robotic Surgery Integration
Virtual Surgical Planning (VSP) capabilities can enhance robotic-assisted surgery by providing detailed 3D models and plans, enabling robotic systems to execute procedures with increased precision and consistency.
Surgical Navigation Accuracy
Patient-specific surgical instruments (PSIs) are designed to improve surgical accuracy through better implant positioning and more precise bone correction, contributing to optimal outcomes.
Pre-Operative Assessment
Generates comprehensive pre-operative surgical plans automatically, allowing surgeons to review and approve. The AI-generated 3D anatomical models offer significant insight into patient joint anatomies, facilitating a more thorough preoperative dialogue and identification of potential challenges.
Post-Operative Monitoring
Not explicitly detailed as a current feature of this specific tool. While AI can potentially recommend personalized post-surgical rehab in the future, it's not a stated capability of the current system.
Complication Prediction
The platform facilitates identifying potential challenges during the preoperative planning phase through detailed 3D models and comprehensive dialogue. However, it does not explicitly offer a formal complication prediction system.
Operating Room Workflow Integration
Streamlines the planning process with AI-powered image analysis and offers a cloud-integrated platform for efficient data management and collaboration among surgical teams, engineers, and representatives. Patient-specific instruments are single-use and sterile, potentially reducing instrument trays and shortening opening times in the OR.
Physician Tip

Leverage the AI-driven 3D planning from X-rays or CTs for highly personalized knee arthroplasty, especially with the United Orthopedic U2 Knee System. The precision offered by patient-specific instrumentation can significantly improve implant positioning and bone correction. Utilize the collaborative cloud-based platform for efficient case management and review with your team. Note the benefit of reduced radiation exposure with X-ray based planning. This system is indicated for patients without severe bone deformities (HKA greater than 15u00b0 or deformities due to prior fracture of the distal femur or proximal tibia).

The system is 510(k) cleared and specifically designed for use with the United Orthopedic U2 Knee System. It integrates with 3D Systems for the additive manufacturing of surgical guides and anatomical models. The cloud-based platform is designed to seamlessly connect with surgical case portals and can be synchronized with ERPs, CRMs, and other business solutions for enhanced workflow efficiency.

Details

Category Surgical AI
Pricing Contact for pricing — Flexible pricing model; pay for features used; scales with case volume
DeploymentCloud-based (AWS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The United Orthopedic Knee Patient Specific Instrumentation received U.S. FDA 510(k) clearance (K230850) on December 20, 2023. It is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems.
Integrations
EHR Not specified
Specialties Orthopedics, Radiology

What the Web Says

United Orthopedic's Patient Specific Instrumentation (PSI) for knee replacement, particularly with their U2 Total Knee System, utilizes AI-driven technology and 3D anatomical modeling from X-ray or CT images to create customized surgical guides. This aims to enhance precision, reduce surgical time, and improve implant alignment in total knee arthroplasty (TKA). While some studies suggest benefits in reducing operating room resources and improving component positioning, there is ongoing debate regarding its consistent superiority in clinical outcomes and cost-effectiveness compared to conventional instrumentation.

Overall: Mixed

Strengths

  • AI-driven precision and 3D anatomical modeling for personalized surgical planning.
  • Reduces reliance on CT-scans for TKA preoperative planning, enabling precise planning for a broader range of patients.
  • Potential for improved accuracy in coronal alignment and fewer outliers.
  • May reduce the number of instrument trays and overall time in the operating room.
  • Can be particularly useful in complex cases or when intramedullary guides cannot be used, such as with post-traumatic femoral deformities.
  • Excellent patient satisfaction and functional scores reported in some mid-term studies when combined with careful surgeon-directed preoperative planning.

Limitations

  • Advantages over conventional instrumentation in routinely improving clinical outcomes remain controversial.
  • Increased costs for imaging and instrument fabrication.
  • Increased preoperative time required for surgical planning and reviewing instrument plans.
  • Requires a learning curve for surgeons to work with engineers and use the instruments intraoperatively.
  • Savings from reduced OR resources may not always compensate for the technology's costs.
  • Minimal evidence of improvement in either alignment or patient outcomes in some studies.

Based on reviews from: Enhatch Reviews Jun 2026: Pricing & Features | SoftwareWorld, Enhatch Reviews, Pricing & Ratings | GetApp NZ 2026, Enhatch Software Pricing, Alternatives & More 2026 | Capterra, Enhatch | Reviews, Pricing & Demos - SoftwareAdvice AU, Enhatch Reviews & Pricing 2026 | Goodfirms, New era for knee 3D planning | Patient-specific surgical guides - Enhatch, The efficacy and safety of patient-specific instrumentation versus conventional instrumentation for unicompartmental knee arthroplasty: Evidence from a meta-analysis - PMC, U2 PSA Knee | United Orthopedic Corporation | Hip and Knee Implants, USTAR II | United Orthopedic Corporation | Hip and Knee Implants, Hip and Knee Implants - U2 Knee | USA United Orthopedic Corporation, United Orthopedic Knee System - Arthoworld, U2 PSA Knee Surgical Technique Guide - United Orthopedic, U2 Knee AiO Surgical Technique Guide | United Orthopedic, Patient-specific Instruments for Total Knee Arthroplasty | restor3d, Surgical Protocol - UOC Suisse - United Orthopedic, United Orthopedic Corporation Enrolls First Patient in U2 Knee System Study | ODT, Computer-Assisted Surgical Navigation for Musculoskeletal Procedures u2013 Community Plan Medical Policy - UHC Provider Portal, Medical Professional Download (Archived Document) | United Orthopedic Corporation | Hip and Knee Implants, Patient specific instrumentation in total knee arthroplasty: a state of the art - PMC, THINK Surgical and United Orthopedic Corporation Announce Collaboration to Deliver Enhanced Precision and Pursue Reproducible Outcomes in Total Knee Replacements - PR Newswire, Does the use of patient-specific instrumentation improve resource use in the operating room and outcome after total knee arthroplasty?u2013A multicenter study | PLOS One, Clinical outcomes after using patient specific instrumentation: is it worth the effort? A minimum 5-year retrospective review of 298 PSI knees - PMC, Unicompartmental knee arthroplasty: Current indications, technical issues and results - PMC, Custom Implants in TKA Provide No Substantial Benefit in Terms of Outcome Scores, Reoperation Risk, or Mean Alignment: A Systematic Review - PMC, Hip and Knee Implants | United Orthopedic Corporation

Last updated: 2026-07-21

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Press & Coverage

Innolitics
United Orthopedic Knee Patient Specific Instrumentation (K230850) u2014 FDA 510(k)
This FDA 510(k) premarket notification details the clearance of United Orthopedic Knee Patient Specific Instrumentation, an orthopedic instrument system designed to assist in positioning total knee arthroplasty systems. The document outlines the indications for use, regulatory classification, and substantial equivalence to predicate devices.
2023-12
Enhatch
Enhatch | Radiology AI Companies - X-ray Interpreter
Enhatch, Inc. developed the United Orthopedic Knee Patient Specific Instrumentation, an AI-powered system that processes CT and X-ray images for 3D surgical planning. This article highlights its release and FDA regulatory approval.
2023-12
PMC
Advancing Musculoskeletal Care Using AI and Digital Health Applications: A Review of Commercial Solutions
This review article discusses the role of AI and digital health in musculoskeletal care, mentioning United Orthopedic Knee Patient Specific Instrumentation as an example of patient-specific surgical instrumentation for intraoperative support based on preoperative planning. It emphasizes how such technologies respect individual patient anatomy.
2025-05
Innolitics
Command Line as a Medical Device (CLaMD)
This article discusses the concept of 'Command Line as a Medical Device' and references Enhatch, Inc.'s United Orthopedic Knee Patient Specific Instrumentation, noting its SaaS preoperative planning workflow where technicians interface with the software to provide outputs to the end-user surgeon.
2025-05
FDA
510(k) Premarket Notification
This official FDA document confirms the 510(k) premarket notification for United Orthopedic Knee Patient Specific Instrumentation, listing Enhatch, Inc. as the applicant and Monica Williams as the contact. It provides regulatory details including the regulation number and classification product code.
2026-06

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Frequently Asked Questions

United Orthopedic's PSI, specifically the Intelligent Surgery Knee system, leverages advanced AI algorithms for accurate X-ray or CT segmentation, transforming imaging data into detailed 3D anatomical models. This AI-powered planning assists in optimizing implant selection and positioning for the U2 Total Knee System, aiming to enhance surgical precision and patient-specific care.
The Intelligent Surgery Knee system, which includes AI-powered segmentation and implant recognition engines, is 510(k) cleared by the FDA, indicating it adheres to regulatory standards for medical devices. United Orthopedic emphasizes compliance with applicable 21 Code of Federal Regulations (CFR) requirements and maintains quality management systems that comply with FDA and CE requirements.
Alternatives to AI-driven PSI include conventional cutting instruments, computer-assisted navigation systems (CAS), and robot-assisted systems (RAS). While PSI aims to improve accuracy and efficiency by shifting planning preoperatively, some studies suggest mixed results regarding alignment improvement and surgical efficiency compared to conventional methods.
While specific pricing details for United Orthopedic's AI-powered PSI are not readily available in public search results, patient-specific instruments generally involve increased costs for imaging and instrument fabrication. However, potential savings can arise from reduced operating room time and potentially lower rates of implant failure or revision, though studies on overall cost-effectiveness have shown mixed results.
The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15u00b0 or deformities due to prior fracture of the distal femur or proximal tibia. AI algorithms, in general, may face challenges with biased training data, incomplete datasets, and under-representation of certain populations, requiring ongoing refinement.
Formal United Orthopedic Knee Patient Specific Instrumentation training is recommended prior to use of the system. The AI-driven system is designed for precision and adaptability, aiming to integrate into current surgical processes and streamline planning.
The Intelligent Surgery Knee Segmentation Engine processes medical imaging data (DICOM), which is a standard for image exchange, implying a degree of interoperability with PACS systems. While direct integration with EHRs for broader data leveraging is a general trend in healthcare AI, specific details for United Orthopedic's PSI are not explicitly stated, but interoperability is crucial for comprehensive patient records and improved care.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed United Orthopedic Knee Patient Specific Instrumentation

Funded through the company that built this tool.

Index Ventures
VC T1
London, United Kingdom
unknown
Index Ventures is a transatlantic firm with offices in London, San Francisco, and New York, and a portfolio that has produced category…
AI/ML in Healthcare Biotech
Floodgate
VC T3
Menlo Park, United States
$250k-$1M
Floodgate is a Bay Area early-stage venture firm with a long track record of high-conviction seed and pre-seed investing, with a generalist…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
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