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510(k) Data Aggregation

    K Number
    K190474
    Device Name
    MectaLock PEEK Suture Anchor
    Manufacturer
    Medacta International SA
    Date Cleared
    2019-05-28

    (90 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K160605,K170455,K181970,K100006,K061863
    Why did this record match?
    Device Name :

    MectaLock PEEK Suture Anchor

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

    The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures:

    · Hip: acetabular labral repair; and

    · Shoulder: glenoid labrum repair.

    Device Description

    The MectaLock PEEK® Suture Anchor is an implantable device used for soft tissue re-fixation (i.e.: muscles, tendons, ligaments...) composed of an anchoring component (PEEK® anchor) and an Ultra High Molecular Weight PolyEthylene non-absorbable braided suture. The MectaLock PEEK® Suture Anchor is a knotless device provided mounted on the tip of a dedicated disposable driver which allows the surgeon to insert the anchor into a pilot hole, previously drilled in the desired position into the patient's bone. The surgeon must combine the MectaLock PEEK® Suture Anchor with the provided non-absorbable UHMWPE suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed. The MectaLock PEEK® Suture Anchor portfolio is composed of three anchor sizes: ø2.4, ø2.9, and ø3.4mm combined with two driver lengths: short and long.

    AI/ML Overview

    The provided text is a 510(k) summary for the MectaLock PEEK Suture Anchor. It is a regulatory submission for a medical device that does not involve an AI/ML algorithm.

    Therefore, the requested information about acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, experts for ground truth, MRMC studies) is not present in this document. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance testing (e.g., design validation, characterization testing, pyrogenicity, sterilization) to establish substantial equivalence to a legally marketed predicate device. It explicitly states: "No clinical studies were conducted."

    Because this document is not about an AI/ML device, I cannot fulfill the request for information specific to AI/ML device studies.

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