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510(k) Data Aggregation

    K Number
    K242302
    Device Name
    RejuvaKnee™ Collagen Meniscus Implant
    Manufacturer
    Collagen Matrix, Inc.
    Date Cleared
    2024-10-02

    (58 days)

    Product Code
    OLC
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing 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 RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.
    Device Description
    The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device 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. RejuvaKnee is supplied sterile and is intended for single use.
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    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?
    Product Code :

    OLC

    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
    K082079
    Device Name
    REGEN COLLAGEN SCAFFOLD (CS)
    Manufacturer
    REGEN BIOLOGICS, INC.
    Date Cleared
    2008-12-18

    (148 days)

    Product Code
    OLC
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing 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 CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.
    Device Description
    The ReGen Collagen Scaffold (CS) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CS 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.
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