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ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors

by DePuy Ireland UC

510(k) K253197

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253197↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253197 Date19 Nov 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 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  • Withdrawn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
JWH
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
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 ATTUNE Total Knee System and ATTUNE Revision Sleeve LPS Femoral Adaptors are orthopedic implants classified under the FDA’s Product Code JWH. These devices are designed for use in total knee arthroplasty and revision procedures, providing femoral adaptors for customised fit and stability in complex knee replacements.

The system is supplied as a sterile, single-use orthopedic implant set, intended for use in surgical settings by trained professionals. It includes components for femoral preparation and revision procedures, adhering to FDA 510(k) clearance and EU MDR compliance. Sizes and adaptors are tailored for specific anatomical applications, with no MRI safety restrictions stated. Authorisation details include K253197 under the Orthopedic Device Facts Record.

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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 surgeries is the ATTUNE Total Knee System and ATTUNE Revision Sleeve LPS Femoral Adaptors designed for?

    The ATTUNE Total Knee System and ATTUNE Revision Sleeve LPS Femoral Adaptors are specifically designed for total knee arthroplasty (replacement) and revision knee surgeries. The femoral adaptors are tailored to provide a customized fit and enhanced stability, particularly in complex cases where anatomical variations require precise adjustments.

  • Are the ATTUNE components meant for reuse in multiple surgeries, or are they single-use?

    The ATTUNE Total Knee System and ATTUNE Revision Sleeve LPS Femoral Adaptors are supplied as a sterile, single-use orthopedic implant set. This ensures patient safety and compliance with surgical best practices, as they are intended for one-time use in a surgical setting.

  • How are the ATTUNE femoral adaptors sized, and do they accommodate different anatomical needs?

    The ATTUNE Revision Sleeve LPS Femoral Adaptors come in sizes and configurations tailored for specific anatomical applications. This customization allows surgeons to select the appropriate adaptor for the patient’s unique bone structure, ensuring a secure and stable fit during revision knee procedures.

  • Can these implants be used in patients who require MRI scans after surgery, or are there any restrictions?

    The ATTUNE Total Knee System and ATTUNE Revision Sleeve LPS Femoral Adaptors do not explicitly state any MRI safety restrictions in the provided documentation. However, it is always recommended to verify compatibility with the specific MRI machine and protocol being used, as safety can depend on individual device components and settings.

  • How is the ATTUNE system regulated, and what does the FDA’s Product Code JWH indicate about its classification?

    The ATTUNE Total Knee System and ATTUNE Revision Sleeve LPS Femoral Adaptors are classified under the FDA’s Product Code JWH, which falls under orthopedic devices. This classification is part of the regulatory pathway that ensures the device meets safety and effectiveness standards for total knee arthroplasty and revision procedures, as determined through a 510(k) clearance process.