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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070961,K122374,K190707
    Why did this record match?
    Reference Devices :

    K070961, K122374, K190707

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device called "SuturePatch Tissue Reinforcement." It does NOT describe an AI/ML device or its acceptance criteria and a study proving it meets them. The text provided is wholly unrelated to AI/ML.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document is for a physical surgical mesh and details its regulatory clearance, not the performance of an AI/ML algorithm.

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