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510(k) Data Aggregation

    K Number
    K253308

    Validate with FDA (Live)

    Device Name
    Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
    Manufacturer
    Materialise N.V
    Date Cleared
    2026-01-07

    (100 days)

    Product Code
    PPT
    Regulation Number
    882.4310
    Type
    Special
    Panel
    Neurology
    Age Range
    0 - 100
    Reference & Predicate Devices
    K111558,K201052,K243637
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K111558, K201052

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CMF Titanium Guides

    CMF Titanium Guides are intended to guide the marking of bone and/or guide surgical instruments in craniofacial surgery.

    CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.

    CMF Titanium Guides are intended for children, adolescents and adults.

    CMF Titanium Guides are intended for single use only.

    CMF Titanium Guides are to be used by a physician trained in the performance of craniomaxillofacial surgery.

    CMF Plastic Models

    CMF Plastic Models are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in craniofacial surgical procedures.

    CMF Plastic Models are intended for infants, children, adolescents and adults.

    CMF Plastic Models are intended for single use only.

    CMF Plastic Models are to be used by a physician trained in the performance of craniomaxillofacial surgery.

    Device Description

    Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D pre-operative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the craniofacial skeleton or in craniomaxillofacial surgeries.

    The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile.

    Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.

    AI/ML Overview

    N/A

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