BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    ATTUNE™ Revision Hinge Knee

    K Number: K242871 · Decision Nov 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    48
    Review Days
    59

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    Basic Information

    Device Name
    ATTUNE™ Revision Hinge Knee
    K Number
    K242871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Ireland UC
    Date Received
    September 23, 2024
    Decision Date
    November 21, 2024
    Product Code
    KRO
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by Depuy Ireland UC

    K Number Device Name
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    K253197 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
    K251292 RECLAIM Monobloc Revision Femoral Stem
    K243977 EMPHASYS Acetabular System
    K243248 INHANCE INTACT™
    K242084 EMPHASYS Acetabular Shell with RapiTite HA
    K241000 ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;
    K240678 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
    Search all 48 clearances from Depuy Ireland UC →