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510(k) Data Aggregation

    K Number
    K172636
    Device Name
    VitaMESH Macroporous PP Surgical Mesh
    Manufacturer
    Proxy Biomedical Ltd.
    Date Cleared
    2018-04-30

    (241 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Proxy Biomedical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing
    Device Description
    The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.
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    K Number
    K111121
    Device Name
    VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Date Cleared
    2011-05-13

    (22 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROXY BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
    Device Description
    VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.
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    K Number
    K060520
    Device Name
    VITAMESH MACROPOROUS PP SURGICAL MESH
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Date Cleared
    2006-03-28

    (29 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROXY BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
    Device Description
    The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
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    K Number
    K052100
    Device Name
    MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Date Cleared
    2005-08-11

    (8 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROXY BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proxy Biomedical MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
    Device Description
    Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The Soft tissue patch measures 0.006" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.
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    K Number
    K051245
    Device Name
    POLYFORM SYNTHETIC MESH
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Date Cleared
    2005-06-17

    (32 days)

    Product Code
    OTO
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROXY BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
    Device Description
    Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.
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    K Number
    K050678
    Device Name
    MOTIFMESH SOFT TISSUE PATCH
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Date Cleared
    2005-05-20

    (65 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROXY BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
    Device Description
    MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The soft tissue patch measures 0.006''+/. 001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
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