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

    EMPOWR Porous Knee System

    K Number: K171991 · Decision Oct 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    81
    Review Days
    93

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    Basic Information

    Device Name
    EMPOWR Porous Knee System
    K Number
    K171991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Medical L.P.
    Date Received
    July 3, 2017
    Decision Date
    October 4, 2017
    Product Code
    MBH
    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
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    Other Clearances by Encore Medical L.P.

    K Number Device Name
    K252567 AltiVate Reverse® ADLC Glenosphere
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    K251833 EMPOWR Acetabular® Liner Extension
    K252141 AltiVate Reverse® Glenoid
    K251776 EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
    K251241 EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
    K251184 AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
    K241483 ceramys™ femoral head system
    K233481 AltiVate Reverse® Glenoid
    K222592 AltiVate® Anatomic Shoulder AG e+™ with Markers
    Search all 81 clearances from Encore Medical L.P. →