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VELYS Robotic-Assisted Solution

by DePuy Ireland UC 3 variants

510(k) K202769

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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202769↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202769 Date14 Jan 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-1029-2022 FDA Class II initiated 11 Mar 2022

    System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment

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  • Withdrawn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
OLO
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 VELYS Robotic-Assisted Solution is a robotic system designed for orthopedic surgery, specifically for knee arthroplasty procedures. It integrates robotic guidance to assist in precise implant positioning, aiming to enhance surgical accuracy and optimize patient outcomes by preserving soft tissue integrity and joint stability.

This system is supplied as a surgical aid for use in operating rooms and is intended for single-use applications. It requires no MRI compatibility considerations and is authorized under FDA 510(k) clearance (K202769) and MDR compliance. The device is paired with compatible implant systems, such as the ATTUNE Total Knee System, and is distributed by DePuy Ireland UC.

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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 knee procedures is the VELYS Robotic-Assisted Solution designed to assist with, and how does it improve surgical outcomes?

    The VELYS Robotic-Assisted Solution is specifically designed for knee arthroplasty procedures, such as total knee replacements. It integrates robotic guidance to assist surgeons in achieving precise implant positioning, which helps preserve soft tissue integrity and enhances joint stability. This precision is intended to optimize patient outcomes by reducing the risk of implant misalignment and improving long-term functionality.

  • Is the VELYS Robotic-Assisted Solution intended for reuse, or is it meant to be used only once per procedure?

    The VELYS Robotic-Assisted Solution is explicitly supplied for single-use applications only. This design ensures patient safety and sterility, as it is not intended to be reused across multiple procedures.

  • What implant systems is the VELYS Robotic-Assisted Solution compatible with, and how does this pairing work?

    The VELYS Robotic-Assisted Solution is designed to work with compatible implant systems, such as the ATTUNE Total Knee System. The robotic system provides surgical guidance during knee arthroplasty, ensuring precise alignment and positioning of these implants, which helps achieve optimal surgical outcomes.

  • Does the VELYS Robotic-Assisted Solution require any special handling or storage conditions, and is it MRI-compatible?

    The VELYS Robotic-Assisted Solution does not require MRI compatibility considerations, meaning it can be safely used in operating rooms where MRI scans are performed nearby. While specific storage conditions are not detailed, standard surgical instrument handling and storage practices should be followed to maintain its integrity and functionality for single-use procedures.