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510(k) Data Aggregation

    K Number
    K152463
    Device Name
    SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
    Manufacturer
    PORIFEROUS LLC
    Date Cleared
    2016-01-20

    (145 days)

    Product Code
    FWP
    Regulation Number
    878.3550
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    Applicant Name (Manufacturer) :

    PORIFEROUS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.
    Device Description
    The SU-POR Patient-Specific Surgical Implant is provided as a kit of two identical implants, one of which serves as a back-up implant. The SU-POR Patient-Specific Surgical Implant also provides the surgeon an option of a non-sterile non-implantable template made of the same high-density porous polyethylene to be utilized by the surgeon to assist in modifying the implant prior to placement. The SU-POR Patient-Specific Surgical Implant is manufactured from high-density porous polyethylene to fit the individual needs of a patient based on design input identified by the surgeon. The interconnecting porous structure of the material allows for host tissue ingrowth. The SU-POR Patient-Specific Surgical Implant may be fixed into place using surgical plates and screws. The SU-POR Patient-Specific Surgical Implant is provided as a single-use sterile device.
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