ROSA Knee System (with OptimiZe)

by Zimmer Biomet  · Based in United States → — A global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health.
Orthopedics
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Regulatory Status Disclosed

Overview

The ROSA Knee System, developed by Zimmer Biomet, is an FDA-cleared robotic surgical assistant specifically designed to enhance precision and personalization in Total Knee Arthroplasty (TKA). This innovative system supports orthopedic surgeons by providing real-time data and robotic guidance, aiming to improve surgical accuracy and ultimately optimize patient outcomes in knee replacement procedures.

At the core of its advanced capabilities is the OptimiZe intelligent data solution, which leverages artificial intelligence and sophisticated data analytics. OptimiZe utilizes pre-operative imaging to create a detailed 3D model of the patient’s knee, enabling customized surgical planning. During the procedure, it provides real-time intraoperative data and visual feedback, guiding surgeons with unparalleled precision for bone resections, soft tissue balancing, and personalized implant positioning tailored to each patient’s unique anatomy.

For physicians, the ROSA Knee System with OptimiZe offers significant clinical advantages. It provides objective, data-driven insights throughout the surgery, allowing for more informed decision-making and consistent execution of the surgical plan. This robotic assistance can lead to reduced variability in surgical outcomes, potentially improving implant longevity and patient satisfaction through better alignment and balance. The system is designed to integrate seamlessly into existing surgical workflows, empowering surgeons with advanced tools without altering their fundamental surgical approach.

Zimmer Biomet is committed to supporting surgical teams in adopting and mastering the ROSA Knee System. They provide comprehensive training and ongoing support to ensure effective utilization, helping physicians leverage the full potential of this robotic platform to deliver high-quality, personalized care in total knee replacement surgery.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Robotic-assisted bone resections
  • Real-time intraoperative data feedback
  • AI-powered personalized surgical planning (OptimiZe)
  • 3D pre-operative planning tools
  • Soft tissue balancing guidance
  • Precise implant positioning
  • Optical tracking technology
  • Intraoperative navigation

Use Cases

  • Total Knee Arthroplasty (TKA)
  • Personalized surgical planning for knee replacement
  • Intraoperative guidance for bone cuts
  • Optimizing implant alignment and balance

What Physicians Need to Know

Surgical Planning Capabilities
OptimiZe Planningu2122 creates customized surgical plans based on surgeon's knee balancing preferences, with the ability to generate personalized surgical plans from customized profiles, potentially reducing planning time by an average of 46%. It supports both functional and automated kinematic alignment approaches. The system offers flexible imaging options, including imageless and image-based planning, and uses pre-operative X-rays to create a 3D model for a custom surgical blueprint. It also allows for objective measurement of soft tissue and predictive planning of a balanced knee replacement before resections.
Intraoperative Guidance
The system provides continuous real-time data to the surgeon, functioning like a GPS system that adjusts for even the tiniest movements of the leg. OptimiZe Trackingu2122 enables collaborative resections with motion-sensitive Active Tracku2122, eliminating the need to pin the Cut Guide to the bone and ensuring bony resections remain on plane despite leg movement. It assists with bone resections and assesses soft tissues to facilitate precise implant positioning intra-operatively, offering real-time feedback on soft tissues, femoral rotation, and ligament tension.
3D Reconstruction Quality
The ROSA Knee System utilizes a series of X-rays to generate a 3D model of the patient's unique knee anatomy for pre-operative planning. For image-based cases, a 3D virtual bone model is generated pre-operatively using the PSI system with X-Atlasu00ae 2D to 3D Technology.
Robotic Surgery Integration
ROSA, a 'Robotic Surgical Assistant,' is a collaborative robotic system where the surgeon maintains control while collaborating with a smart robotic tool to enhance accuracy and reproducibility in total knee arthroplasty (TKA). It features a semi-autonomous robotic arm that assists in placing the cutting jig and performing ligament laxity assessments. The system integrates with the Personau00ae Knee System to facilitate personalized and anatomically accurate implant placement.
Surgical Navigation Accuracy
The system is designed to deliver accurate and reproducible outcomes by reducing landmark variability and improving precision to the pre-operative plan for optimal implant placement. OptimiZe Landmarkingu2122 specifically reduces user landmarking variability. Studies show high accuracy in femoral and tibial resection levels, particularly in the coronal plane, with minimal outliers and reliable predictions for femoral and tibial angles. Femoral component size prediction is highly accurate, with 75% exact matches and 98.18% within one size.
Pre-Operative Assessment
OptimiZe Planningu2122 allows for the creation of customized surgical plans based on individual surgeon preferences and patient anatomy. The system uses pre-operative X-rays to generate a 3D model of the knee for detailed planning. It can objectively measure soft tissue and predictively plan a balanced knee replacement before any resections are performed.
Post-Operative Monitoring
The ROSA Knee System integrates with ZBEdgeu00ae Analytics, a data platform that provides intra-operative, mobility, and outcome insights directly to a smartphone. This enables surgeons to objectively assess their performance, understand the potential impact of clinical decisions on patient recovery, and monitor and benchmark their progress over time. The OrthoIntel Orthopedic Intelligence Platform captures pre- and post-operative metrics, including steps, PROMs (KOOS Jr.), and stand time.
Complication Prediction
While not a direct 'complication prediction' tool, the integration with ZBEdgeu00ae Analytics allows surgeons to understand the potential impact of clinical decisions on patient recovery, which can indirectly contribute to reducing complications. Robotic-assisted TKA with ROSA has been associated with fewer complications and improved early post-operative functional status compared to non-technology-assisted TKA.
Operating Room Workflow Integration
The system is designed to enhance surgical efficiency and features a simplified user interface (OptimiZe Experienceu2122) that allows surgeons to tailor workflow and display options. It enables surgeons to maintain their existing surgical workflow while optimizing the robotic experience. The ROSA Knee System has a minimal initial learning curve, with a rapid reduction in operative time typically observed after the first 10 cases. It also offers rapid intra-operative assessment of medial and lateral extension gap characteristics and has been shown to result in less physician stress and strain compared to conventional methods.
Physician Tip

Leverage OptimiZe Planningu2122 to create highly personalized surgical plans based on your preferred knee balancing and alignment philosophies, including functional or automated kinematic alignment. Utilize the real-time intraoperative guidance, especially OptimiZe Trackingu2122 and Landmarkingu2122, to enhance precision and reduce variability during bone resections and implant placement. Actively engage with ZBEdgeu00ae Analytics to gain data-driven insights into your performance and patient outcomes, which can inform continuous improvement in your surgical approach and patient care pathways. The system's minimal learning curve and intuitive interface are designed to integrate smoothly into existing OR workflows, allowing for efficient adoption and enhanced surgical experience.

The ROSA Knee System (with OptimiZe) seamlessly integrates with Zimmer Biomet's Personau00ae Knee System for personalized and anatomically accurate implants. Crucially, it connects with ZBEdgeu00ae Analytics, a comprehensive data platform that delivers intra-operative, mobility, and outcome insights directly to a smartphone, facilitating data-driven decision-making and post-operative monitoring. The system also incorporates X-Atlasu00ae 2D to 3D Technology for pre-operative planning and 3D modeling.

Details

Category Surgical AI
Pricing Contact for pricing
  • The ROSA Knee System costs around $700,000 for a hospital to acquire (as of 2022)
  • For patients, robotic-assisted knee replacement surgery using ROSA is generally considered to be an equivalent price to traditional knee replacement surgery, with no additional cost to the patient, though the overall procedure may be more expensive for the provider
Free Trial No
DeploymentOn-premise
Mobile AppYes
Data Export Yes
LanguagesEnglish
Training Yes
Target Sizehospitals and large orthopedic practices
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The original ROSA Knee System received U.S. FDA 510(k) clearance in January 2019. The enhanced version, ROSA Knee with OptimiZe, received U.S. FDA 510(k) clearance on November 14, 2025. This enhanced version offers customized surgical planning, new positioning, tracking, and alignment features for robotic-assisted total knee replacement surgery.
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Orthopedics

Social Proof

Customersunknown
Notable
unknown

Support & Reliability

Training Provided Yes

What the Web Says

The ROSA Knee System with OptimiZe is a robotic-assisted surgical system designed to enhance total knee replacement procedures by providing surgeons with real-time data and precise measurements. It aims to personalize surgical plans, improve implant positioning and alignment, and potentially lead to better patient outcomes. The OptimiZe version offers intelligent surgical planning and new positioning, tracking, and alignment features for a more customized experience.

Overall: Positive

Strengths

  • Improved accuracy and precision in implant placement and alignment.
  • Personalized surgical planning based on a 3D model of the patient's unique anatomy.
  • Potential for smaller incisions, reduced scarring, and less blood loss.
  • May lead to less post-operative pain, shorter hospital stays, and quicker recovery times.
  • Reduced risk of implant misalignment and associated complications.
  • Surgeons maintain control of the cutting device, offering a familiar feel.

Limitations

  • Operative time may be longer, especially during the learning curve for surgeons.
  • Requires specialized training for surgeons to use the system effectively.
  • Not every patient is a candidate for ROSA Knee replacement; physician discretion is necessary.
  • Potential risks and complications inherent to any surgery, such as pain, bleeding, infection, or stiffness.

Based on reviews from: A Personal Journey through, and review of, the Landscape of Surgical Robotics in Knee Arthroplasty: My Transition from Makou00ae to NAVIOu2122 and finally to the ROSAu00ae Knee System, Zimmer Biomet's enhanced version of Rosa earns FDA clearance - Becker's Spine Review, Total Knee Replacement Townsville | Dr Jonathon de Hoog - Aspire Orthopaedics, ROSAu00ae Robotic Knee Replacement: What You Need To Know, Physicians Surgical Hospitals Highlights Potential Benefits Of Rosau00ae Knee System For Total Knee Replacement, 10 Things to know about ROSA Robotic Knee Surgery - Monument Health, Learn about ROSA Knee robotic technology u2013 a total knee replacement solution that is specific to each unique anatomy. - Facebook, ROSA Robotic Total Knee Replacement - Samuel A. Moore, D.O. Orthopedic Surgeon &u200b Sport Medicine, ROSA Robotic Knee Replacement Troy | Degenerative Joint Disease Michigan, Q&A About ROSAu00ae Knee System | Methodist McKinney Hospital

Last updated: 2026-08-29

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Press & Coverage

Aspire Orthopaedics
Total Knee Replacement Townsville | Dr Jonathon de Hoog - Aspire Orthopaedics
Dr. Jonathon de Hoog utilizes the ROSA Knee system with OptimiZe for total knee replacements, highlighting its role in improving component positioning accuracy and reducing alignment outliers. The system uses pre-operative imaging to create a 3D model and a personalized surgical plan, providing real-time guidance during the operation.
unknown

Videos

Product demos, reviews, and walkthroughs for ROSA Knee System (with OptimiZe).

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Frequently Asked Questions

The ROSA Knee System with OptimiZe is designed to be surgeon-centered, allowing you to maintain your current surgical approach and technique while enhancing the robotic experience through customized surgeon profiles. It provides intelligent planning tools, real-time tracking, and a simplified user interface to streamline workflow and improve efficiency in total knee arthroplasty.
OptimiZe introduces enhanced features like OptimiZe Planning for personalized surgical plans and reduced preoperative planning time, OptimiZe Landmarking to minimize user variability, and OptimiZe Tracking for collaborative resections without pinning the cut guide to the bone. It also offers automated Kinematic Alignment planning, which is unique among robotic systems, and a simplified user interface for a tailored experience.
Studies indicate that robotic-assisted TKA with systems like ROSA Knee can lead to improved accuracy of bone resections and overall limb alignment, with fewer outliers compared to conventional techniques. Early literature suggests potential benefits such as shorter hospital stays, quicker recovery times, and improved functional outcomes, though long-term data are still evolving.
While generally accurate, one study noted that the ROSA system's accuracy in the sagittal plane was less consistent compared to the coronal plane. Additionally, robotic platforms can initially increase operative time, though a rapid learning curve has been reported, leading to significant reductions in time after the first few cases.
ROSA Knee with OptimiZe offers flexibility with both image-based (X-ray for 3D model) and imageless planning options, whereas systems like Mako typically rely on preoperative CT scans. A key distinction is that ROSA uses a cutting guide, with the surgeon performing the bone cuts, while Mako utilizes a robotic arm with a saw or burr that operates within haptically controlled virtual boundaries.
Specific acquisition costs for the ROSA Knee System are typically a capital expenditure for the institution and are not publicly disclosed. However, the system's ability to use imageless options can reduce costs associated with preoperative CT scans and may lead to efficiencies through reduced instrumentation and potentially shorter operative times, contributing to overall cost-effectiveness.
The ROSA Knee System with OptimiZe has received U.S. FDA 510(k) clearance, indicating its compliance with regulatory standards for medical devices. It integrates with ZBEdge Analytics, allowing surgeons to access intraoperative data for performance assessment and decision-making, while Zimmer Biomet emphasizes its commitment to product security and corporate compliance.

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Suggest an Edit → | Last Verified: 2026-05-27 | First Added: 2026-05-27
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