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    K Number
    K171114
    Device Name
    HEALIX ADVANCE KNOTLESS Anchor
    Manufacturer
    Medos International SARL
    Date Cleared
    2017-11-27

    (227 days)

    Product Code
    MAI,MBI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K130917,K131974,K130539,K131683,K101679,K082810,K071177,K061863,K051219
    Predicate For
    K180101,K241010
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

    Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

    Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

    Foot/Ankle*: Achilles Tendon Repair
    *HEALIX ADVANCE KNOTLESS PEEK Anchors only

    Device Description

    The HEALIX ADVANCE™ KNOTLESS Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE™ KNOTLESS Anchors are molded from Biocryl Rapide® (BR) and polyetheretherketone (PEEK) materials. The HEALIX ADVANCE™ KNOTLESS Anchor is provided sterile and is for single use only.

    AI/ML Overview

    The provided text describes a medical device, the HEALIX ADVANCE™ KNOTLESS Anchor, and its substantial equivalence to predicate devices. It focuses on the device's design, materials, and clinical indications for use, as well as the non-clinical testing performed.

    However, the document does not contain information related to an AI/ML device. Therefore, I am unable to provide a response to your request, as it specifically asks for acceptance criteria and study details for a device supported by AI/ML.

    The text discusses:

    • Device Name: HEALIX ADVANCE™ KNOTLESS Anchor
    • Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
    • Regulatory Class: Class II
    • Product Codes: MAI, MBI
    • Indications for Use: Reattachment of soft tissue to bone in procedures involving the shoulder (Rotator Cuff, Biceps Tenodesis, Deltoid Repair), knee (Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis), and Foot/Ankle (Achilles Tendon Repair - PEEK Anchors only).
    • Non-clinical Testing: In-vitro anchor pull out, time zero anchor pull out, torque testing, biological, sterility, packaging, and shelf-life evaluations.

    This information pertains to a physical medical implant and its mechanical performance, not to an AI/ML diagnostic or predictive tool.

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