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510(k) Data Aggregation

    K Number
    K253895

    Validate with FDA (Live)

    Device Name
    Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2025-12-30

    (26 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K193575,K150648,K230435
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K193575,K150648,K230435

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

    The Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is intended to be used for suture or tissue fixation in the foot/ankle and hand/wrist. Specific indications for use are listed below:

    • Hand/Wrist: Repair of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
    • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus Reconstruction
    Device Description

    The proposed Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is a knotless, two-component suture anchor consisting of a fully threaded and vented anchor body and a closed eyelet. The anchor and eyelet are manufactured from polyetheretherketone (PEEK Optima per ASTM F2026). The anchor and eyelet are preassembled on a disposable inserter with a suture threader. Arthrex recommends the use of the Arthrex 1.3 mm SutureTape (sold separately) previously cleared within Arthrex SutureTape (K193575). The proposed device is offered sterile, single-use, and is packaged in a single-pack (one per box).

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