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

    Catalyst F1x Shoulder System

    K Number: K252418 · Decision Nov 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    12
    Review Days
    97

    Basic Information

    Device Name
    Catalyst F1x Shoulder System
    K Number
    K252418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Catalyst Orthoscience, Inc.
    Date Received
    August 1, 2025
    Decision Date
    November 6, 2025
    Product Code
    KWS
    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
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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    Other Clearances by Catalyst Orthoscience, Inc.

    K Number Device Name
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    K222317 Catalyst EA Convertible Stemmed Shoulder
    K213349 Catalyst R1 Reverse Shoulder System
    K211991 Catalyst R1 Reverse Shoulder System
    K202611 Catalyst OrthoScience R1 Reverse Shoulder System
    K191811 Catalyst OrthoScience CSR Shoulder System
    K182500 Catalyst CSR Press-Fit Humeral Components
    K181287 Catalyst CSR Shoulder System
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