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510(k) Data Aggregation

    K Number
    K171465
    Device Name
    Stryker Self-Punching ICONIX
    Manufacturer
    Stryker
    Date Cleared
    2017-08-24

    (98 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K170098,K063778,K092533,K162310,K133671,K133224
    Why did this record match?
    Reference Devices :

    K170098, K063778, K092533, K162310

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

    The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the elbow, shoulder, knee and hip. See indications below.

    Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

    Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

    Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

    Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

    Device Description

    The Self-Punching ICONIX Anchors (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor preloaded on the inserter is packaged in a single-use sterile barrier system (SBS).

    AI/ML Overview

    The provided text is a 510(k) summary for the Stryker Self-Punching ICONIX, a medical device for soft-tissue to bone fixation. It does not describe a study involving acceptance criteria and a device's performance against them in the context of an AI/algorithm-based diagnostic or prognostic device.

    Instead, this document describes and demonstrates the substantial equivalence of a new medical device (Stryker Self-Punching ICONIX Anchors) to existing predicate devices based on non-clinical benchtop testing. The performance data presented focuses on fixation strength and insertion effort, not on diagnostic accuracy, sensitivity, specificity, or reader performance in an AI context.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not addressed in this document for the described device.

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