LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K200398
    Device Name
    AxSOS 3 AF System and AxSOS 3 Ti System
    Manufacturer
    Stryker GmbH
    Date Cleared
    2020-06-05

    (108 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K163650,K181091,K024060,K050512,K190586
    Why did this record match?
    Device Name :

    AxSOS 3 AF System and AxSOS 3 Ti System

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

    The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the includes tibio-talo-calcaneal, tibiotalar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies of the distal tibia, talus, and calcaneus.

    AxSOS 3 Ti is intended for long bone fracture fixation.
    Indications include:

    • · Diaphyseal, metaphyseal, extra- and intra-articular fractures
    • · Non-unions and malunions
    • · Normal and osteopenic bone
    • · Osteotomies
    • · Periprosthetic fractures of the femur and proximal tibia

    The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:

    • · Periprosthetic fractures
    • · Diaphyseal and metaphyseal areas of long bones in pediatric patients

    The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
    Screws can also be used for arthrodesis.

    Device Description

    AxSOS 3 AF (Ankle Fusion) is an internal fixation system composed of sterile and non-sterile plates, and associated instruments. These plates are available in a variety of anatomical orientations and made of titanium alloy, with Type II anodization, and used with compatible screws.

    AxSOS 3 Ti is an internal fixation system composed of sterile and non-sterile plates, screws, and complementary, implantable devices, along with associated instruments. The plates are available in a variety of anatomical orientations and lengths. Implants of this system are available in titanium alloy, with Type II anodization.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or specific studies proving a device meets these criteria. The document is a 510(k) premarket notification for the AxSOS 3 AF System and AxSOS 3 Ti System, which details the device's indications for use, technological characteristics, and a summary of non-clinical performance data (mechanical testing and MR compatibility).

    It explicitly states: "Clinical testing was not a requirement for this submission."

    Therefore, I cannot extract the information required for your request, as clinical acceptance criteria, detailed performance results demonstrating meeting those criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details are not present in this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1