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510(k) Data Aggregation

    K Number
    K242442
    Device Name
    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
    Manufacturer
    Innovate Orthopaedics Ltd
    Date Cleared
    2025-01-31

    (168 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K212547,K231819
    Why did this record match?
    Reference Devices :

    K212547

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

    Quick-Start Screws are indicated for interference fixation of grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.

    Device Description

    The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of grafts in ligament reconstruction procedures such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw." This type of document primarily confirms substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or a comprehensive premarket submission that would elaborate on acceptance criteria and performance data for AI/ML-based devices.

    The document discusses the physical characteristics and intended use of the orthopedic screws, with a focus on demonstrating equivalence to an already cleared predicate device (K231819). It mentions "bench testing" to support the use of the screws with synthetic grafts but does not provide specific performance metrics, sample sizes, or details about the methodology (e.g., ground truth establishment, expert adjudication) that would be relevant to an AI/ML-based device's validation.

    Therefore, the information required to answer your request about acceptance criteria and study details for an AI/ML device is not present in the provided text. The document describes a traditional medical device (orthopedic screws) and its regulatory clearance process, not an AI/ML-driven diagnostic or therapeutic system.

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