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

    Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

    K Number: K162256 · Decision Oct 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    21
    Review Days
    77

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    Basic Information

    Device Name
    Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
    K Number
    K162256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Total Joint Orthopedics, Inc.
    Date Received
    August 11, 2016
    Decision Date
    October 27, 2016
    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 Total Joint Orthopedics, Inc.

    K Number Device Name
    K220483 Platform® Acetabular System
    K211877 Klassic Knee System
    K211602 Klassic Knee System
    K202740 Klassic Knee System Tibial Inserts, PS-Max
    K183596 Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
    K190280 Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
    K180929 Klassic HD® Hip System
    K180159 Klassic® Knee System
    K173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
    K162422 Klassic Knee System
    Search all 21 clearances from Total Joint Orthopedics, Inc. →