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VELYS Robotic-Assisted Solution

by DePuy Ireland UC

510(k) K240211

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 found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240211↗

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 · Traditional NumberK240211 Date5 Jun 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 minimally invasive neurosurgical procedures, specifically for the treatment of neurological conditions. It integrates robotic precision with surgical tools to enhance accuracy and control during procedures such as deep brain stimulation or other targeted interventions within the brain.

This device is supplied as a reusable system and is intended for use in sterile operating room environments. It is classified under the product code OLO and has received FDA clearance via a 510(k) submission, with a decision dated June 5, 2024. The system is regulated under the Medical Device Regulation (MDR) and is intended for use in settings where advanced neurosurgical support is required, adhering to strict sterility and safety protocols.

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

    The VELYS Robotic-Assisted Solution is specifically designed for minimally invasive neurosurgical procedures, particularly for targeted interventions like deep brain stimulation. By integrating robotic precision with surgical tools, it enhances accuracy and control, which can help reduce procedural risks, improve targeting precision, and support more consistent outcomes in complex neurological treatments.

  • Is the VELYS system reusable, and if so, what considerations should be taken into account for its use in sterile operating room environments?

    Yes, the VELYS Robotic-Assisted Solution is supplied as a reusable system. Since it is intended for sterile operating room environments, proper sterilization protocols must be followed before each use to ensure patient safety and device integrity. The system’s design supports repeated use in clinical settings where advanced neurosurgical precision is required.

  • How is the VELYS system regulated, and what regulatory bodies oversee its compliance and approval?

    The VELYS Robotic-Assisted Solution has received FDA clearance through a 510(k) submission, classified under product code OLO, with a decision dated June 5, 2024. It is also regulated under the Medical Device Regulation (MDR), ensuring compliance with both U.S. and EU standards for advanced medical devices. The system’s regulatory pathway reflects its status as a high-precision neurosurgical tool.

  • What should clinicians know about the advisory committee involvement in the VELYS system’s approval process?

    The VELYS system’s FDA clearance was reviewed by the Orthopaedic and Rehabilitation Devices Advisory Committee (OR), with input from the Neurology specialty panel (NE). This advisory review ensured the device’s safety and effectiveness for its intended use in minimally invasive neurosurgery, particularly for procedures requiring robotic-assisted precision.

  • How does the VELYS system’s reusable design impact its maintenance and long-term clinical use?

    As a reusable system, the VELYS Robotic-Assisted Solution requires adherence to strict maintenance protocols to ensure reliability, sterility, and performance consistency across procedures. Hospitals must implement robust cleaning, sterilization, and calibration procedures to sustain its functionality in high-precision neurosurgical applications over time.