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510(k) Data Aggregation

    K Number
    K162193
    Device Name
    XenMatrix AB Surgical Graft
    Manufacturer
    C.R. Bard
    Date Cleared
    2016-12-23

    (141 days)

    Product Code
    PIJ, FTM, OXH
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XenMatrix™ AB Surgical Graft is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
    Device Description
    The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated prior to use. The proposed XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline. The coating is shaded orange in color due to the color of the antimicrobial agents.
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    K Number
    K151177
    Device Name
    XenMatrix AB Surgical Graft
    Manufacturer
    C.R. Bard
    Date Cleared
    2015-07-30

    (90 days)

    Product Code
    PIJ, FTM, OXH
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XenMatrix™ AB Surgical Graft is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
    Device Description
    The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated in sterile saline prior to use. The proposed XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline. The coating is shaded orange in color due to the color of the antimicrobial agents.
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    K Number
    K133223
    Device Name
    XENMATRIX AB SURGICAL GRAFT
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2014-09-19

    (333 days)

    Product Code
    PIJ, FTM, OXH
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
    Device Description
    The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated in sterile saline prior to use. The thickness of the device is 1.5 to 2.3mm. The XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline at 180 µg/cm each. The coating is shaded orange in color due to the color of the antimicrobial agents. The bioresorbable L - Tyrosine succinate polymer is essentially absorbed in 12 months based on in vitro studies. The antimicrobial coating present on this device is intended to protect the graft from bacterial colonization.
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