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510(k) Data Aggregation

    K Number
    K151468
    Device Name
    ARIX Wrist System
    Manufacturer
    Jeil Medical Corporation
    Date Cleared
    2016-01-14

    (227 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K103332,K142906
    Predicate For
    K170705,K191972,K243368
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.

    Device Description

    The ARIX Wrist System is consists of the Radius & Ulna. It is rigid fixation plates and screws which were recommended combination as follow;
    Type / Configuration: Radius, Ulna
    Plate: 25-DVRA Series, 25-DLUL Series
    Screw: Self-tapping Cortical Screw (25-HF Series), Self-tapping Locking Screw (161.0325 Series for Radius, 25L-HF Series for Ulna)
    Material: ASTM F 67 Pure Titanium (Plate), ASTM F 136 Titanium Alloy (Ti-6Al-4V) (Screws)
    The ARIX Wrist System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The self-tapping cortical screws & self-tapping locking screws diameter is 2.5mm and lengths is from 8mm to 38mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc,. The ARIX Wrist System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery.

    AI/ML Overview

    This document is a 510(k) premarket notification for the "ARIX Wrist System" and does not contain information about an AI/ML powered device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, and AI/ML specific aspects from this document.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices for a medical implant (bone plates and screws) through material composition, design features, and non-clinical bench testing.

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