LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K230857

    Validate with FDA (Live)

    Device Name
    TiLink-P SI Joint Fusion System
    Manufacturer
    Surgentec, LLC
    Date Cleared
    2023-09-25

    (180 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K180818,K221047
    Predicate For
    K240720
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

    Device Description

    The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.

    The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor and along the SI Joint via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. The document is an FDA 510(k) clearance letter for a TiLink-P SI Joint Fusion System, which is a physical implant for sacroiliac joint fusion, not an AI/ML device.

    Therefore, I cannot provide the requested information, including:

    1. Table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    Instead, the document details the regulatory clearance for a medical implant and lists non-clinical performance data for mechanical testing, biocompatibility, sterilization validation, and a side-by-side cadaver study to demonstrate substantial equivalence to predicate devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1