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510(k) Data Aggregation

    K Number
    K260561

    Validate with FDA (Live)

    Device Name
    Arthrex FiberTak Suture Anchor
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-20

    (29 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K221396,K251809,K060478
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    • 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 and Reconstruction, Gluteal Tendon Repair

    The 1.8 Knotless FiberTak® Soft Anchor with #2 Suture is also intended to be used for osteochondral fixation and fractures, including surgeries with autograft and allograft tissues, in the Knee and Hip.

    Device Description

    The Arthrex FiberTak Suture Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The anchor (sheath) and connected sutures are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and/or Polyester. The subject anchors are impacted into a pilot hole via their inserter. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sheath within the pilot hole. The subject devices are provided sterile (Ethylene Oxide), are single-use, and are packaged in a dual-barrier configuration.

    AI/ML Overview

    N/A

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