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Arvis Shoulder

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243950

by Kico Knee Innovation Company Pty Ltd

Identifiers

510(k) Number
K243950 FDA 510(k)
FDA Product Code
SBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Orthopedic Augmented Reality device, as classified under FDA product code SBF, is a specialized system designed to assist in shoulder surgery procedures. It integrates augmented reality technology to provide real-time visualization and guidance, enhancing precision during orthopedic interventions.

This device is intended for use in surgical settings and is supplied as a reusable system, adhering to FDA 510(k) clearance and EU MDR compliance. It is not MRI-safe and requires proper storage and handling as specified by the manufacturer. The device’s regulatory authorizations include FDA clearance and MDR compliance, ensuring adherence to stringent safety and performance standards.

Frequently asked questions

What types of shoulder surgeries is the ARVIS® Shoulder designed to assist with, and how does augmented reality enhance the procedure?

The ARVIS® Shoulder is an orthopedic augmented reality system intended to provide real-time visualization and guidance during shoulder surgery procedures. It integrates augmented reality technology to enhance precision by overlaying critical anatomical and surgical information onto the operative field, helping surgeons navigate complex procedures with improved accuracy and confidence.

Is the ARVIS® Shoulder system reusable, and what storage or handling requirements should be followed to maintain its performance?

Yes, the ARVIS® Shoulder is supplied as a reusable system. Since it is not MRI-safe, it must be stored and handled according to the manufacturer’s guidelines to ensure proper functionality and longevity. Specific storage conditions, such as environmental protection and cleaning protocols, should be followed to prevent damage or contamination.

What regulatory pathways does the ARVIS® Shoulder follow, and how does this ensure its safety and performance?

The ARVIS® Shoulder has obtained FDA 510(k) clearance and complies with EU MDR (Medical Device Regulation) standards. These pathways ensure that the device meets stringent safety, performance, and quality requirements before entering the market, providing assurance to clinicians and patients of its reliability in surgical settings.

How is the ARVIS® Shoulder classified under FDA regulations, and what does this classification imply for its use?

The ARVIS® Shoulder is classified under FDA product code SBF (Surgical and Orthopedic Devices, Bone Growth Stimulators, and Related Devices) and is designated as a Class II device. This classification implies that it is subject to special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance, while still allowing for innovation in orthopedic augmented reality assistance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kico Knee Innovation Company Pty Ltd
FDA Applicant
Kico Knee Innovation Company Pty, Ltd.

Sources (2)

  • FDA 510(k) K243950 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026