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510(k) Data Aggregation

    K Number
    K181769
    Device Name
    Arthrex FiberTak Suture Anchor
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2018-09-21

    (80 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K151230,K140855
    Why did this record match?
    Reference Devices :

    K151230, K140855

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

    • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

    • Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

    • Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

    • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

    · Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

    · Hip: Acetabular labral repair.

    Device Description

    The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

    The anchor is constructed from a hollow braid of polyester with a single or double loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for single use.

    AI/ML Overview

    The provided text is a 510(k) summary for the Arthrex FiberTak Suture Anchor. It details the device's purpose, description, and indications for use, and then discusses performance data.

    However, the information provided does not contain details about a study evaluating an AI/Algorithmic device's performance against specific acceptance criteria, or an MRMC study. The "Performance Data" section solely refers to:

    • Tensile testing to demonstrate the new FiberTak models perform statistically equivalent to the predicate and meet acceptance criteria for hip acetabular labral repair indications. This relates to the physical strength and function of the surgical anchor, not an AI or algorithmic medical device.
    • Bacterial endotoxin testing to ensure the device meets pyrogen limit specifications. This relates to the sterility and safety of the physical device.

    Therefore, I cannot fulfill your request for information regarding AI/algorithmic device acceptance criteria and study details based on the provided text. The document describes a traditional medical device (a suture anchor), not an AI-powered diagnostic or therapeutic tool.

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