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510(k) Data Aggregation

    K Number
    K252949

    Validate with FDA (Live)

    Device Name
    Geminus Volar Distal Radius Plating System
    Manufacturer
    Skeletal Dynamics Inc
    Date Cleared
    2025-11-13

    (58 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K935481,K122310,K122737,K242436,K241815,K963798,K182492
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Skeletal Dynamics Geminus Volar Distal Radius Plating System is intended for fixation of fractures and osteotomies of the distal radius.

    Device Description

    The current Geminus Volar Distal Radius Plating System includes medical grade titanium alloy (Ti 6Al-V4 ELI) bone plates offered in 12 sizes, an ulnar hook plate, Cobalt-Chromium-Molybdenum (CoCrMo) and titanium alloy (Ti 6Al-V4 ELI) bone screws and pegs, and specialized instrumentation for the repair of distal radius and osteotomies. The system also includes the Radial Hook Plate extensions to buttress a volar marginal fragment, and the Buttress Button assembly to capture and hold small dorsal corner fractures.

    The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

    The Geminus Volar Distal Radius Plating System is comprised of:

    System ComponentsMaterial(s)Standard(s)
    Geminus Volar Distal Radius PlatesTi 6Al-V4 ELIASTM F136
    Locking Smooth PegsLocking Threaded PegsHigh Compression Locking PegsNon-Locking Threaded PegsCortical Non-Locking ScrewsCortical Locking ScrewsTi 6Al-V4 ELIASTM F136
    Washer ButtonTi 6Al-V4 ELIASTM F136
    Polyaxial Locking ScrewsCoCrMoASTM F1537
    Geminus Hook Plate ScrewsTi 6Al-V4 ELIASTM F136
    Geminus Ulnar Hook PlateTi 6Al-V4 ELIASTM F136
    Geminus Radial Hook PlateTi 6Al-V4 ELIASTM F136
    Geminus Buttress Button AssemblyTi 6Al-V4 ELICP Ti Grade 2ASTM F136ASTM F86
    AI/ML Overview

    N/A

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