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

    Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

    K Number: K180612 · Decision Jun 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    9
    Review Days
    91

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    Basic Information

    Device Name
    Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
    K Number
    K180612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
    Date Received
    March 8, 2018
    Decision Date
    June 7, 2018
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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    Other Clearances by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

    K Number Device Name
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    K191358 Trident II Acetabular System
    K182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
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    K171768 Trident® II Acetabular System
    K161569 Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws