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510(k) Data Aggregation

    K Number
    K231330
    Device Name
    FiberTak® Suture Anchor
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2023-06-01

    (24 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K203268,K230568
    Why did this record match?
    Device Name :

    FiberTak**®** Suture Anchor

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

    The FiberTak® Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

    The FiberTak® Suture Anchors are intended for the following indications:

    • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
    • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
    • Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/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, Joint Capsule Closure
    • Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

    Device Description

    The FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (FiberTak® Suture Anchor) and does not contain the information requested about acceptance criteria and a study proving device performance as it relates to AI/ML or diagnostic performance.

    The document describes performance data as:

    • Ultimate load testing and cyclic displacement: Performed to demonstrate that differences in the subject device (a line extension) do not negatively impact mechanical strength compared to the predicate device.
    • Bacterial endotoxin per USP : Conducted to demonstrate that the device meets pyrogen limit specifications.

    These tests are standard for evaluating the mechanical and biocompatibility aspects of a physical medical device, not the diagnostic or predictive performance of an AI/ML algorithm.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on this document.

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