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510(k) Data Aggregation

    K Number
    K250865

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-14

    (238 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KLS Martin IPS Forearm System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or will not be crossed by fixation.

    Device Description

    The KLS Martin Individual Patient Solutions (IPS) Forearm System is comprised of additively manufactured, patient-specific models, guides and metallic bone plates. The plates will be used in conjunction with previously cleared metallic bone screws and locking pins for internal fixation, alignment, stabilization, reconstruction, and/or corrective osteotomies of the radius and/or ulna. The devices are designed and manufactured to be patient-specific based on the electronic medical image of the patient's anatomy; with input from the physician during virtual planning, prior to finalization, and prior to production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an appropriate fit.

    Implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. The system also includes the necessary fixation devices and instruments to facilitate placement of the implants.

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