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

    Progressive Orthopedic Total Knee System

    K Number: K142649 · Decision Mar 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    5
    Review Days
    188

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    Basic Information

    Device Name
    Progressive Orthopedic Total Knee System
    K Number
    K142649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Progressive Orthopaedic Company, LLC
    Date Received
    September 17, 2014
    Decision Date
    March 24, 2015
    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 The Progressive Orthopaedic Company, LLC

    K Number Device Name
    K183344 The Progressive Orthopaedic Company Total Knee System II
    K151424 The Progressive Orthopaedic Total Hip System
    K150783 Progressive Orthopaedic Total Knee System
    K143314 Progressive Orthopaedic Total Hip System