BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    JARVIS Diaphyseal Stem Standard

    K Number: K253345 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    9
    Review Days
    29

    Basic Information

    Device Name
    JARVIS Diaphyseal Stem Standard
    K Number
    K253345
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FH Industrie
    Date Received
    September 30, 2025
    Decision Date
    October 29, 2025
    Product Code
    PHX
    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
    PHX Shoulder Prosthesis, Reverse Configuration

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PHX), ordered by most recent decision date.

    Augment Off-Axis Instrument System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSS - Humeral reverse liners extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Veritas Reverse Total Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Equinoxe® Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by FH Industrie

    K Number Device Name
    K254003 JARVIS Metaphyseal Stem
    K252411 JARVIS Glenoid Reverse Shoulder Prosthesis
    K242253 JARVIS Glenoid Reverse Shoulder Prosthesis
    K232226 ARROW Off-Centred Humeral Insert
    K220758 e-Ortho Shoulder Software v1.1
    K202024 ARROW Short Stem Humeral System
    K200127 TELEGRAPH® EVOLUTION Humeral Nailing System
    K201928 e-Ortho Shoulder Software