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510(k) Data Aggregation

    K Number
    K180670
    Device Name
    ICONN Campbell Interference Screw
    Manufacturer
    ICONN Orthopedics, LLC
    Date Cleared
    2018-12-07

    (268 days)

    Product Code
    HWC,MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K062466
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ICONN Campbell Interference Screw System is intended for fixation of tissue, including ligament or tendon to bone for the following indications:

    Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

    Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

    Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.

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

    Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist, Lateral Epicondylitis repair.

    Device Description

    The ICONN Campbell Interference Screws (various part numbers) are sterile (gamma irradiation), single use implantable devices available in two materials: Solvay's Zeniva®ZA-600L polyetheretherketone (PEEK) or Ti 6Al-4 ELI (Grade 23) and is intended for fixation of tissue, including ligament or tendon to bone. The screws are available in multiple sizes ranging from diameters of Ø6mm - Ø12mm in 1mm increments. The Ø6mm screw is available only in 20mm long, the Ø7mm - Ø10mm screws are available in 20mm and 25mm lengths, and the Ø11mm and Ø12mm screws are available in 25mm lengths only.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the ICONN Campbell Interference Screw:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Mechanical Performance
    Axial Pullout Strength (after cyclic loading)Similar or better than the predicate device (Arthrex PEEK Interference Screw) OR within acceptable ranges for the intended use.Performed similarly or better than the predicate OR within acceptable ranges for the intended use.
    Displacement during Cyclic LoadingSimilar or better than the predicate device (Arthrex PEEK Interference Screw) OR within acceptable ranges for the intended use.Performed similarly or better than the predicate OR within acceptable ranges for the intended use.
    Torsional Properties (Insertion Testing)Device can be safely implanted.Testing results showed that the device can be safely implanted.
    Driving Torque (Insertion Testing)Device can be safely implanted.Testing results showed that the device can be safely implanted.
    Biocompatibility
    CytotoxicityMet acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013).Met acceptance criteria.
    IrritationMet acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013).Met acceptance criteria.
    SensitizationMet acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013).Met acceptance criteria.
    Endotoxin (LAL Test)
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