LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110800
    Device Name
    META-LOCK SUTURE ANCHOR SYSTEM
    Manufacturer
    TARSUS MEDICAL INC.
    Date Cleared
    2011-09-27

    (189 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K051989
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below:

    SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, Deltoid repair

    ANKLE: Lateral instability, medial instability, achilles tendon repair/reconstruction, Midfoot reconstructions

    FOOT: Hallux valgus reconstruction

    WRIST: Scapholunate ligament

    HAND: Ulnar or lateral collateral ligament reconstruction

    ELBOW: Biceps tendon reattachment

    KNEE: Extra capsular repairs; reattachment of : medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions.

    Device Description

    The Meta-Lock™ Suture Anchor System is a suture anchor used for the reattachment of soft tissue to bone.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Meta-Lock™ Suture Anchor System) and does not contain the information requested about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

    The document discusses:

    • Device Type: A traditional medical device (suture anchor system).
    • Approval Type: 510(k) premarket notification.
    • Performance Evaluation: Non-clinical tests (tensile testing, cyclic testing, MR testing, galvanic corrosion testing, simulated movement, and simulated use testing) to demonstrate substantial equivalence to a predicate device, not to establish novel performance against specific acceptance criteria in the way an AI/algorithm would be tested.
    • Human Involvement: Not relevant as it's a physical implant, not an AI assisting human readers.
    • Ground Truth: Not applicable in the context of this physical device's non-clinical testing.
    • Training Set: Not applicable.

    Therefore, I cannot extract the requested information (points 1-9) from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1