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ARVIS Shoulder

by Kico Knee Innovation Company Pty Ltd

510(k) K243950

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243950↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK243950 Date13 Jan 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2957-2026 FDA Class II initiated 13 Jul 2026

    Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

    • Ongoing Z-0145-2026 FDA Class II initiated 19 Sep 2025

    Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
SBF
FDA applicant
Kico Knee Innovation Company Pty, Ltd.
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Other devices from Kico Knee Innovation Company Pty Ltd

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.