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    K Number
    K210228
    Device Name
    KLS Martin IPS Preprosthetic
    Manufacturer
    KLS-Martin L.P.
    Date Cleared
    2022-07-08

    (526 days)

    Product Code
    ELE
    Regulation Number
    872.3645
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures.
    Device Description
    The KLS Martin Individual Patient Solutions (IPS) Preprosthetic system is comprised of patient-specific models and metallic bone plates with integrated pillars used in conjunction with metallic bone screws for internal fixation of the implant to maxillofacial / midface and mandibular bones. The integrated pillars will serve as the base for temporary dentures as well as a permanent prosthesis. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only 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 adequate fit. The KLS Martin IPS Planning System is utilized to plan and design the IPS Preprosthetic implant. The IPS Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, implants, and case reports. Implants are provided non-sterile, range in thickness from 1.2 - 10.0 mm, and are manufactured using additive methods from Ti-6Al-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws. Implants have a minimum of two (2) transgingival pillars for the attachment of dental prostheses. The straight pillars (0° to the occlusal plane) have a diameter of 4 mm and are provided at lengths up to 20 mm.
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