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

    b-ONE® Total Hip System

    K Number: K240528 · Decision Nov 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    12
    Review Days
    266

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    Basic Information

    Device Name
    b-ONE® Total Hip System
    K Number
    K240528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-One Ortho, Corp.
    Date Received
    February 23, 2024
    Decision Date
    November 15, 2024
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    Other Clearances by B-One Ortho, Corp.

    K Number Device Name
    K253357 b-ONE® Bipolar Head
    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
    K210483 MOBIO Total Knee 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. →