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510(k) Data Aggregation

    K Number
    K254229

    Validate with FDA (Live)

    Device Name
    Arthrex Nano FiberTak Suture Anchor
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-02

    (63 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K110879,K203268,K181513
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nano FiberTak Suture Anchor is intended to be used for soft tissue to bone fixation with indications for use in:

    Hand and Wrist
    Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor, and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.

    Device Description

    The Arthrex Nano FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with a push-in design preloaded on an inserter with needles. The anchor (sheath) and connected sutures are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyester. The device is provided sterile (Ethylene Oxide) and is packaged in a dual-barrier configuration for single-use.

    AI/ML Overview

    N/A

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