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510(k) Data Aggregation

    K Number
    K251567
    Device Name
    NovoSorb BTM
    Manufacturer
    PolyNovo Biomaterials Pty Ltd
    Date Cleared
    2025-06-20

    (29 days)

    Product Code
    QSZ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PolyNovo Biomaterials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoSorb BTM is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
    Device Description
    The NovoSorb BTM device has been modified to expand the available thickness of the foam component from 2 mm to 2-6 mm. Sizes are limited to a maximum volume of 160 cm³. The device continues to be a porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the foam. The sealing membrane is to be removed and discarded when appropriate, leaving only the foam layer to biodegrade in patients. NovoSorb BTM is a terminally sterilized, single use device intended for deep partial and full thickness wounds. Each NovoSorb BTM is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
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    K Number
    K242149
    Device Name
    NovoSorb® MTX
    Manufacturer
    PolyNovo Biomaterials Pty Ltd
    Date Cleared
    2025-03-05

    (225 days)

    Product Code
    QSZ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PolyNovo Biomaterials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoSorb® MTX is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for single use only.
    Device Description
    NovoSorb® MTX is a fully synthetic biodegradable device that is composed of a single foam layer. The foam is a 2-6 mm thick, white, open cell degradable foam with a high degree of porosity (>90%) providing a scaffold for dermal tissue integration. NovoSorb® MTX will be supplied in sizes ranging from 4 cm2 to 800 cm2 with a maximum volume of 160 cm³. NovoSorb® MTX is a terminally sterilized, single use device intended for deep partial and full thickness wounds. It is intended for use by qualified healthcare professionals in a hospital/clinical environment and is not intended for use at home. Each NovoSorb® MTX is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
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    K Number
    K221686
    Device Name
    NovoSorb Matrix
    Manufacturer
    PolyNovo Biomaterials Pty Ltd
    Date Cleared
    2022-09-15

    (97 days)

    Product Code
    QSZ, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PolyNovo Biomaterials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoSorb® Matrix is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, partial thickness burns, and skin tears) and draining wounds.
    Device Description
    Not Found
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    K Number
    K172140
    Device Name
    NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
    Manufacturer
    PolyNovo Biomaterials Pty Ltd
    Date Cleared
    2017-08-11

    (25 days)

    Product Code
    QSZ, FRO, OSZ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PolyNovo Biomaterials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is for single use only.
    Device Description
    The NovoSorb™ BTM Wound Dressing device is a 2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative water loss during integration of the foam. The adhesive layer and sealing membrane are to be removed and discarded when appropriate leaving only the foam layer to biodegrade in patients. NovoSorb™ BTM Wound Dressing device is supplied in various sizes, ranging from 4cm² to 800cm². The NovoSorb™ BTM Wound Dressing is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in a white aluminized pouch contained in a cardboard envelope.
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    K Number
    K142879
    Device Name
    BTM Wound Dressing
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Date Cleared
    2015-12-23

    (447 days)

    Product Code
    QSZ, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYNOVO BIOMATERIALS PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTM Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for one-time use.
    Device Description
    The BTM Wound dressing is a biodegradable dermal covering that is comprised of three layers: Biodegradable Layer: 1. Foam A wound-facing, 2mm thick, white, open cell degradable foam with a high degree of porosity (>90%) designed to subsequently biodegrade. The foam is a biocompatible, biodegradable polyurethane material. Removable Layer: 2. Adhesive (bonding) layer A polyurethane bonding layer which bonds the Foam and Sealing Membrane together. 3. Sealing Membrane A transparent polyurethane membrane designed to physiologically close the wound and limit evaporative water loss. The sealing membrane is designed to remain attached to the dermal foam, if required, for at least 30 days in vivo. The BTM Wound dressing is supplied in various sizes, ranging from 10cm x 10cm, up to 20cm x 40cm. The dressings are single use, terminally sterilized devices, individually packed in a polymer pouch within an aluminized envelope.
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    K Number
    K132936
    Device Name
    NOVOPORE DRESSING
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Date Cleared
    2014-03-04

    (167 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYNOVO BIOMATERIALS PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoPore™ is intended to be used as part of a Negative Pressure Wound Therapy (NPWT) system. When used in conjunction with a NPWT system, it is intended to remove excess exudate, infectious material, and tissue debris from wounds which may promote wound healing. NPWT systems are indicated for use on chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), explored fistulas, flaps, and grafts.
    Device Description
    The NovoPore™ Dressing is a polyurethane foam wound dressing used as an accessory to powered suction pumps. The single-use dressing is packaged in a peelable oriented polyamide / polyethylene bag and is sterilized by gamma irradiation. The NovoPore™ Dressing is available in one size: medium.
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