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510(k) Data Aggregation

    K Number
    K251690
    Device Name
    Arthrex SpeedFLEX™ Implant
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2025-09-30

    (120 days)

    Product Code
    OWY
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K120479,K103787
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

    Device Description

    The Arthrex SpeedFLEX™ Implant consists of a decellularized human allograft dermis that is pre-sutured with FiberWire® suture (passing suture) and TigerLink™ SutureTape (implanted). The allograft implant will be offered in four (4) sizes. The Arthrex SpeedFLEX™ Implant is sold sterile, single use.

    AI/ML Overview

    N/A

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