FDA 510(k)

ATTUNE Revision Hinge Knee

K-Number: K242871 · 2024-11-21

Decision Date2024-11-21

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ATTUNE Revision Hinge Knee is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2024-11-21 under approval number K242871. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTUNE Revision Hinge Knee?

ATTUNE Revision Hinge Knee is a medical device that received FDA 510(k) clearance on 2024-11-21. It is manufactured by Depuy Ireland UC. The 510(k) number is K242871.

When was ATTUNE Revision Hinge Knee approved by the FDA?

ATTUNE Revision Hinge Knee received FDA 510(k) clearance on 2024-11-21, under approval number K242871.

What company makes ATTUNE Revision Hinge Knee?

ATTUNE Revision Hinge Knee is manufactured by Depuy Ireland UC.

What is the FDA product code for ATTUNE Revision Hinge Knee?

The FDA product code for ATTUNE Revision Hinge Knee is KRO.

Related Clinical Trials

NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING

Other Devices by Depuy Ireland UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K202098GLOBAL UNITE Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System

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Related Devices (Code: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K191779Attune Revision LPS InsertsDepuy(Ireland)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.