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510(k) Data Aggregation

    K Number
    K202806
    Device Name
    Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
    Manufacturer
    OSTEONIC Co., Ltd.
    Date Cleared
    2021-06-17

    (267 days)

    Product Code
    MAI,MBI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K192484,K181774,K172016,K192032
    Predicate For
    K231326,K243467
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

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

    Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

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

    Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

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

    Device Description

    The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

    This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

    AI/ML Overview

    The furnished document is an FDA 510(k) Premarket Notification for the medical device "Fix2Lock". This document is a clearance letter, not a study report for an AI/ML medical device. It pertains to a bone fixation screw and its substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive technology.

    Therefore, the document does not contain the information requested in the prompt regarding:

    • Acceptance criteria and reported device performance for an AI/ML model.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • MRMC comparative effectiveness study details.
    • Standalone algorithm performance.
    • Types of ground truth.
    • How ground truth for training data was established.

    The document discusses non-clinical bench tests to verify the subject device's design specifications and compliance with various ASTM and ISO standards for materials, mechanical performance, sterilization, and packaging. This is for a physical implantable device, not a software algorithm.

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