BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    USTAR II System

    K Number: K190100 · Decision Sep 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    40
    Review Days
    244

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    Basic Information

    Device Name
    USTAR II System
    K Number
    K190100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United Orthopedic Corporation
    Date Received
    January 22, 2019
    Decision Date
    September 23, 2019
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by United Orthopedic Corporation

    K Number Device Name
    K252725 Stem Extension Line (U2 Total Knee System—PSA Type)
    K252303 Stem Extension Line (USTAR II System)
    K243656 U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella
    K242315 Resolve Modular Revision Hip Stem
    K243466 Conformity Stem Extension Line, #0
    K243024 Cellbrick Knee Spacer
    K242249 Conformity Stem Extension Line
    K221705 U2 Total Knee System-PF+
    K221149 U-Motion II Acetabular System-Extension line
    K221675 United U2 femoral head, 22mm delta ceramic head
    Search all 40 clearances from United Orthopedic Corporation →