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510(k) Data Aggregation

    K Number
    K250997
    Device Name
    Integrity™ Implant
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2025-06-17

    (77 days)

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

    OWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243480
    Device Name
    SuturePatch Tissue Reinforcement
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2025-05-29

    (202 days)

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

    OWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues. The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.
    Device Description
    The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.
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    K Number
    K241219
    Device Name
    FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
    Manufacturer
    ZuriMed Technologies AG
    Date Cleared
    2024-12-11

    (224 days)

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

    OWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fiber System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue. The Fiber Locker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
    Device Description
    The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue.
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    K Number
    K223538
    Device Name
    Integrity Implant
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2023-08-17

    (267 days)

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

    OWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state. The Integrity Implant will be made available in 2 sizes: - 20mm X 25mm - 25mm X 30mm The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body. The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.
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