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

    MOBIO Total Knee System

    K Number: K210483 · Decision Apr 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    12
    Review Days
    61

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    Basic Information

    Device Name
    MOBIO Total Knee System
    K Number
    K210483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-One Ortho, Corp.
    Date Received
    February 19, 2021
    Decision Date
    April 21, 2021
    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 B-One Ortho, Corp.

    K Number Device Name
    K253357 b-ONE® Bipolar Head
    K240528 b-ONE® Total Hip System
    K222431 b-ONER MOBIO Total Knee System
    K213673 b-ONE MOBIO Total Knee System
    K212912 OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
    K202768 KOSMO Femoral Stem
    K202429 Mobio Total Knee System
    K182705 Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
    K183025 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
    K180446 b-ONE Total Knee System
    Search all 12 clearances from B-One Ortho, Corp. →