BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

    K Number: K251776 · Decision Jul 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    320
    Registration Numbers
    320
    Same Product Code
    902
    Applicant Total
    22
    Review Days
    28

    Basic Information

    Device Name
    EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
    K Number
    K251776
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Medical, L.P.
    Date Received
    June 10, 2025
    Decision Date
    July 8, 2025
    Product Code
    JWH
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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    Other Clearances by Encore Medical, L.P.

    K Number Device Name
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    K233481 AltiVate Reverse® Glenoid
    K213387 AltiVate® Anatomic Shoulder AG e+™ with Markers
    K213793 EMPOWR Revision Knee
    K210308 EMPOWR Porous Femur with HAnano SurfaceTM
    K203557 EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
    K203026 AltiVate® Anatomic Pegged Glenoid with Markers
    K191325 EMPOWR Partial Knee
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