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510(k) Data Aggregation

    K Number
    K253763

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-29

    (65 days)

    Product Code
    Regulation Number
    888.3040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

    The Y-Knotless™ Flex Anchors may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

    The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:

    1. Shoulder Labrum
    2. MPFL Reconstruction
    3. Foot and Ankle
    4. Biceps
    5. Meniscal Root Repair
    Device Description

    The Y-Knotless™ Flex Anchors are a non-absorbable, all-suture, knotless implant, that are supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The implant anchors are composed of a white flat braided ultra-high molecular weight polyethylene (UHMWPE) suture anchor, a tapered #2 Hi-Fi® repair suture either white/black or green/white/black, and a #2-0 Hi-Fi® shuttle suture, blue and black. The implants are pre-loaded on a disposable driver with sutures cleated to the handle. The anchors require a 1.8 mm pre-drilled bone hole created using Class I, exempt instrumentation.

    AI/ML Overview

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