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FDA 510(k)

ATTUNE™ Revision Hinge Knee

K-Number: K242871 · 2024-11-21

ApplicantDepuy Ireland UC
Decision Date2024-11-21
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE™ Revision Hinge Knee is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2024-11-21 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K242871.

When did ATTUNE™ Revision Hinge Knee receive FDA 510(k) clearance?

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

Who is the listed applicant for ATTUNE™ Revision Hinge Knee?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Depuy Ireland UC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemK260480VELYS™ Robotic-Assisted SolutionK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementK253624INHANCE™ Reverse Shoulder SystemK253551VELYS™ Hip NavigationK253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

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Related Devices (Code: KRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker OrthopaedicsK252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

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.

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