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510(k) Data Aggregation

    K Number
    K260405

    Validate with FDA (Live)

    Device Name
    FiberTape Button
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-09

    (28 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K062747,K241235,K122374,K203495
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FiberTape Button is intended to be used for fixation of bone to bone or soft tissue to bone and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering the FiberTape Button for primary or secondary fixation for ACL, PCL, MCL, POL, LCL, MPFL, ALL, PLC, Quadriceps Tendon, and Patellar Tendon repair and reconstruction and Iliotibial Band tenodesis.

    Device Description

    The FiberTape Button is a suture-button construct comprised of a titanium button and nonabsorbable suture. The device is provided sterile and is single-use.

    AI/ML Overview

    N/A

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