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510(k) Data Aggregation

    K Number
    K170364
    Device Name
    Collagen Meniscus Implant XL
    Manufacturer
    Ivy Sports Medicine, LLC
    Date Cleared
    2017-05-02

    (85 days)

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

    Ivy Sports Medicine, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ivy Sports Medicine Collagen Meniscus Implant (CMI) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CMI must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CMI reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CMI is not a prosthetic device and is not intended to replace normal body structure.
    Device Description
    The Ivy Sports Medicine Collagen Meniscus Implant XL (CMI XL) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CMI is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue. The CMI XL is provided sterile for single use only.
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    K Number
    K153087
    Device Name
    IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
    Manufacturer
    Ivy Sports Medicine, LLC
    Date Cleared
    2016-07-14

    (262 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Sports Medicine, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The lvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The lvyAlR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
    Device Description
    The IvyAIR Meniscus System is an all-inside meniscus repair device. Each device includes two non-absorbable polymer implants, pre-tied with 2-0 non-absorbable suture and pre-loaded into a needle delivery system. The IvyAIR System is available in three needle configurations: Curved. Straight and Reverse Curve to allow the surgeon a choice for access to the desired zone of the meniscus. The IvyAIR Meniscus System is provided sterile for single use only.
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