LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202444
    Device Name
    Knotless TensionTight Button Implant System
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2020-11-17

    (83 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K122374,K181769,K123341,K061863
    Why did this record match?
    Device Name :

    Knotless TensionTight Button Implant System

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

    The Knotless TensionTight Button Implant System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:
    • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
    • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
    • Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
    • 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
    • Hip: Acetabular Labral Repair

    Device Description

    The Knotless TensionTight Button Implant System consists of an oblong Titanium alloy button with locking trap door preloaded on an inserter with a suture threader and nitinol loop and two Arthrex #5 FiberLink sutures (K122374). The button and sutures are packaged with class I exempt instrumentation.

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a medical device called the "Knotless TensionTight Button Implant System." It does not describe an AI/ML powered device, and therefore does not contain the information requested in your prompt regarding acceptance criteria for AI algorithm performance or related studies (such as MRMC studies, ground truth establishment, or training/test set details).

    The information provided pertains to the regulatory clearance of a mechanical implant system, with performance data focused on mechanical properties (static and dynamic pull-out testing) and biocompatibility, not AI algorithm performance.

    Therefore, I cannot extract the requested information about AI acceptance criteria and study details from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1