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510(k) Data Aggregation

    K Number
    K093844
    Device Name
    SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2010-04-01

    (107 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K011299,K032197,K082215
    Why did this record match?
    Reference Devices :

    K011299, K032197

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

    The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart repairs SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot/Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Midfoot reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Illiotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

    Device Description

    The TWINFIX Ultra HA is a suture anchor manufactured from PLLA-HA and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter.

    AI/ML Overview

    The provided document is a 510(k) summary for the Smith & Nephew TWINFIX Ultra HA Suture Anchor. It details the device's intended use and a comparison to predicate devices, but it does not contain the specific information required to answer the prompt regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document states: "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra HA suture anchors are substantially equivalent to the predicates; Twinfix AB 5.0 cleared via K011299 and the Twinfix AB 6.5 cleared via K032197."

    However, it does not provide the actual acceptance criteria or the reported device performance metrics from these tests. It only makes a general statement about substantial equivalence.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as requested.

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