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510(k) K242871

ATTUNE™ Revision Hinge Knee by Depuy Ireland UC — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2024
Date Received
September 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

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  • K240211 — VELYS Robotic-Assisted Solution (June 5, 2024)

Other clearances for product code KRO

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  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
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  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)
  • K223528 — Triathlon® Hinge Knee System (January 20, 2023)
  • K220628 — LINK Endo-Model EVO Knee System (May 3, 2022)