ARVIS® Shoulder

by Enovis  · Based in United States → — Augmented Reality Visual & Information System
Orthopedics
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Regulatory Status Disclosed

Overview

ARVIS® Shoulder is a computer-controlled surgical navigation system designed for shoulder arthroplasty. It leverages augmented reality (AR) to provide surgeons with real-time, hands-free guidance directly within their field of view during procedures. The system integrates specialized software, electronic hardware (including a wearable eyepiece with tracking cameras and a belt pack), and surgical instruments to intraoperatively track tools and precisely locate anatomical structures. It aids surgeons in executing approved preoperative plans, which are created using patient-specific CT scans and AI-based automatic image segmentation and landmarking algorithms. ARVIS® Shoulder is intended to assist in the accurate selection and positioning of orthopedic implant components, enhancing surgical precision and potentially improving patient outcomes in total shoulder replacement surgeries.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Computer-controlled surgical navigation system for shoulder arthroplasty
  • Augmented Reality (AR) eyepiece for real-time, hands-free visual guidance
  • Operated by gaze and voice control, keeping surgeon in control
  • Intraoperative tracking of surgical tools and anatomical structures
  • Preoperative CT-based planning with AI-based automatic image segmentation and landmarking
  • Surgical guidance information displayed directly over the operative field
  • Aids in precise selection and positioning of orthopedic implant components
  • Compatible with specific shoulder implant systems (e.g., Enovis AltiVateu00ae, LimaCorporate PRIMAu2122, SMRu2122)
  • Portable, self-contained system with no external equipment or large footprint
  • Utilizes reusable instruments to minimize per-procedure costs

Use Cases

  • Performing total shoulder arthroplasty procedures
  • Assisting surgeons with accurate implant positioning and alignment
  • Navigating complex shoulder cases involving bone deformity or loss
  • Enhancing surgeon training and education in shoulder replacement techniques
  • Streamlining surgical workflow in various environments, including ASCs and hospitals
  • Personalizing treatment based on patient-specific CT scan data

What Physicians Need to Know

Surgical Planning Capabilities
ARVISu00ae Shoulder requires a patient's preoperative CT scan to create a surgical plan, including a landmarked digital bone model, which is then matched to intraoperative landmarks. Surgeons can virtually plan the procedure in 3D, including implant sizing and positioning, based on the patient's unique anatomy.
Intraoperative Guidance
The system provides real-time, hands-free surgical guidance through augmented reality overlays directly in the surgeon's field of view. It offers holographic visualization of patient-specific anatomy and implant positioning, along with dynamic tracking of instruments and implants. Cameras in the eyepiece measure locations and angles between trackers on the patient and instruments, providing continuous feedback.
3D Reconstruction Quality
High-quality patient-specific 3D anatomical models are generated from preoperative CT scans, forming the basis for both surgical planning and the holographic visualization provided during surgery.
Robotic Surgery Integration
ARVISu00ae is a surgeon-controlled system, operated by hands-free gaze and voice, designed to keep the surgeon in control without the need for a robot or technician. It is presented as a space-conserving and cost-effective alternative to traditional robotic systems.
Surgical Navigation Accuracy
The system is engineered to deliver precise implant positioning and accurate alignment, providing real-time feedback on alignment and trajectory. Published research indicates that computer-assisted planning and navigation, such as ARVISu00ae, improve surgical accuracy compared to unguided techniques.
Pre-Operative Assessment
Pre-operative assessment is integral to the ARVISu00ae workflow, requiring a patient's CT scan to create a detailed surgical plan tailored to their unique anatomy. This allows for individualized surgical experience.
Operating Room Workflow Integration
ARVISu00ae is designed for seamless integration into existing OR workflows, offering a wearable, self-contained system with hands-free operation (gaze and voice control) and an intuitive user interface. This minimizes clutter and external equipment, enhancing efficiency. It is compatible with an ARVIS augmented reality headband or Strykeru00ae Flyteu00ae/T7u00ae helmets.
Physician Tip

Leverage the comprehensive 3D pre-operative planning capabilities for complex shoulder cases to optimize implant sizing and positioning. Utilize the real-time, hands-free augmented reality guidance to maintain focus directly on the surgical field while receiving precise feedback on alignment and trajectory. Ensure a high-quality pre-operative CT scan is obtained, as it is foundational for the system's planning and intraoperative accuracy. The surgeon remains in complete control, using gaze and voice commands for an intuitive experience.

ARVISu00ae Shoulder is specifically indicated for use with Enovis AltiVateu00ae, LimaCorporate PRIMAu2122, and LimaCorporate SMRu2122 implant systems. It is a self-contained system, minimizing the need for external equipment, and integrates with 'Precision AI Surgical Planning Software' for pre-operative planning. The system's eyepiece can be worn with the ARVIS augmented reality headband or compatible surgical helmets like Strykeru00ae Flyteu00ae or T7u00ae.

Details

Category Surgical AI
Pricing Contact vendor
DeploymentWearable device (headset/eyepiece) with a belt pack containing the computer module.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ARVIS® Shoulder (K243950) received FDA clearance (Substantially Equivalent determination) on January 12, 2025, submitted by Kico Knee Innovation Company Pty Ltd. It is classified as an Orthopedic Augmented Reality device (Product Code SBF, Regulation Number 882.4560).
Integrations
EHR Not specified
Specialties Orthopedics

What the Web Says

The ARVISu00ae Shoulder system from Enovis is a mixed reality navigation system designed to enhance precision and efficiency in shoulder arthroplasty. It provides real-time, intraoperative guidance without the need for preoperative CT scans or additional capital equipment, aiming to improve surgical accuracy and patient outcomes.

Overall: Positive

Strengths

  • Real-time, intraoperative guidance for shoulder arthroplasty.
  • Eliminates the need for preoperative CT scans, reducing radiation exposure and planning time.
  • No additional capital equipment required, integrating with existing surgical tools.
  • Designed to improve surgical precision and accuracy.
  • Potential for enhanced patient outcomes due to more accurate implant placement.
  • Mixed reality interface offers an intuitive and immersive experience for surgeons.

Limitations

  • New technology adoption can have a learning curve for surgeons.
  • Reliance on digital tracking could introduce potential technical glitches.
  • Limited long-term outcome data currently available compared to traditional methods.
  • Cost of the system or per-procedure use might be a factor for some institutions.
  • Potential for distraction from the mixed reality overlay if not optimally designed.
  • Specific feedback from Reddit, G2, and Capterra is not readily available for this specialized medical device.

Based on reviews from: Enovis Official Website, Orthopedic Surgeons (general sentiment from medical forums/articles), Healthcare Technology Reviewers (general sentiment), Medical Device Industry Publications

Last updated: 2026-07-18

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Press & Coverage

Becker's Spine Review
Indiana surgeon completes state's 1st augmented reality shoulder replacement
Dr. Brian Badman performed Indiana's first augmented reality-assisted shoulder replacement using the Enovis ARVIS shoulder system, a headset that provides real-time visual guidance to surgeons. This technology aims to improve implant accuracy, streamline procedures, and enhance surgical focus, eliminating the need for bulky equipment or preoperative CT scans.
2025-08
Becker's Spine Review
Arizona orthopedic surgeon performs state's 1st AR shoulder replacement
Dr. Shelden Martin of OrthoArizona performed Arizona's first augmented reality-assisted shoulder replacement using the Enovis ARVIS system, which provides real-time visual guidance and eliminates the need for 3D-printed guides. The procedure was performed on a patient with degenerative arthritis and rotator cuff pathology.
2026-07
PR Newswire (OrthoArizona)
OrthoArizona Surgeon Performs First Augmented Reality Shoulder Replacement in Arizona
Dr. Shelden Martin of OrthoArizona successfully completed the first augmented reality (AR) assisted shoulder replacement in Arizona using the ARVISu00ae Augmented Reality System by Enovis. This wearable, self-contained system provides real-time, hands-free surgical guidance, marking a significant advancement in precision for shoulder surgery.
2026-07
University Orthopedics Blog
UOI's Dr. Andrew Green Becomes First Surgeon in New England to Use ARVISu00ae Augmented Reality System for Joint Replacement Surgery
Dr. Andrew Green of University Orthopedics became the first surgeon in New England to use the ARVISu00ae Augmented Reality System for shoulder joint replacement surgery. This Enovisu2122 platform offers surgical navigation for precise implant placement within a compact system.
2025-06
UKNow (University of Kentucky)
The future of surgery: Augmented reality enhances UK residents' skillset - UKNow
Orthopedic surgery residents at the University of Kentucky College of Medicine are training with the ARVISu00ae Augmented Reality System by Enovis, a wearable headpiece that provides real-time, hands-free surgical guidance for procedures like shoulder replacements. This technology personalizes treatment based on patient CT scans and aims to improve surgical accuracy, especially in complex cases.
2025-04
MarketBeat
Enovis Q1 2026 Earnings Report
Enovis reported that ARVIS shoulder cases have commenced, with positive early feedback and expectations for continued adoption throughout 2026. The company also completed its first ARVIS shoulder case outside the U.S. in South Africa.
2026-05
FDA
Class 2 Device Recall ARVIS - accessdata.fda.gov
A Class 2 Device Recall was issued for the ARVIS Shoulder Surgical Navigation System (Model ARV-01) due to a complaint regarding the AI surgical planning software that may lead to implant malalignment or decreased range of motion. No actions are required by surgeon users, as affected plans have been quarantined.
2025-10
Manuals.plus
ARVIS Shoulder Surgical Navigation System: Instructions for Use - Manuals.plus
This document provides essential guidance for the ARVISu00ae Shoulder Surgical Navigation System, model ARV-01, by Insight Medical Systems, Inc. It details the system's features, including computer-controlled navigation, intraoperative tracking, and anatomical landmark identification, designed to assist surgeons in precise implant positioning during shoulder arthroplasty.
unknown

Videos

Product demos, reviews, and walkthroughs for ARVIS® Shoulder.

View all on YouTube

Frequently Asked Questions

ARVISu00ae Shoulder is an image-based surgical navigation system that leverages AI for preoperative planning. It uses AI to automatically segment and landmark patient CT scan data, enabling surgeons to precisely plan implant placement and sizing before the procedure. Intraoperatively, it provides real-time, hands-free augmented reality guidance based on this detailed plan.
ARVISu00ae Shoulder is an FDA-cleared system, having received clearance for shoulder replacements in April 2024. To ensure patient data privacy, the system processes minimal data, limits storage time, and aims for accuracy, integrity, and confidentiality, with options to anonymize data for broader use. It also recommends password protection and restricted external communication for the computer module.
ARVISu00ae Shoulder offers real-time, hands-free augmented reality guidance, which published studies indicate can improve surgical accuracy compared to traditional unguided techniques. Unlike larger robotic systems, ARVISu00ae is designed to be compact, more economical, and integrates seamlessly into existing workflows without requiring bulky external equipment.
ARVISu00ae Shoulder is presented as a more economical alternative to traditional robotic systems, featuring a lower system acquisition cost and reduced operating expenses due to reusable components. While specific reimbursement codes for AR-guided shoulder arthroplasty were not detailed in the search results, the system's design emphasizes cost-effectiveness for various surgical environments, including Ambulatory Surgery Centers (ASCs).
The system's navigation output is intended to assist and should not supersede the surgeon's clinical judgment; augmented reality information must always be used alongside displayed stereotaxic data. Contraindications include significant bone loss or excessive soft tissue interfering with landmark identification, and severe osteoporosis at fixation sites. General AI limitations in shoulder surgery also include potential performance variations influenced by new techniques or diverse patient populations.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed ARVIS® Shoulder

Funded through the company that built this tool.

Hoxton Ventures
VC T3
London, United Kingdom
$250k-$1M
Hoxton Ventures is a London-based seed fund led by Hussein Kanji and Rob Kniaz, best known for early checks into Deliveroo, Babylon…
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