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510(k) Data Aggregation

    K Number
    K254233

    Validate with FDA (Live)

    Device Name
    MEDPOR Customized Implant Kit
    Manufacturer
    Stryker Leibinger GmbH & Co KG
    Date Cleared
    2026-03-12

    (73 days)

    Product Code
    FWP
    Regulation Number
    878.3550
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K203055,K191916
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CMF MEDPOR® Customized Implant is indicated for the augmentation, and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

    Device Description

    The CMF MEDPOR® Customized Implant is a patient-specific implant designed at the request of a surgeon. It is comprised of two identical sterile Implants, an optional Host Bone Model, and a Design Proposal. The implants are individually sterilized using ethylene oxide. The customized implants are molded from porous high-density polyethylene (HDPE) to the specific reconstructed boundaries indicated by the surgeon via submission of CT scans and a customized implant request. This submission expands available design options without altering material composition or intended use.

    AI/ML Overview

    N/A

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