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510(k) Data Aggregation

    K Number
    K032709
    Device Name
    MODULAR PLUS HIP STEM
    Manufacturer
    PLUS ORTHOPEDICS
    Date Cleared
    2003-09-23

    (21 days)

    Product Code
    LWJ
    Regulation Number
    888.3360
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K030971
    Why did this record match?
    Device Name :

    MODULAR PLUS HIP STEM

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

    The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.

    Device Description

    The Modular PLUS Revision Stem is a cementless two part modular stem that consists of distal anchorage module and proximal revision module, connected by a multi-stage tapered coupling, secured by a cylindrical screw. The proximal module has a standard 12/14 taper to accept modular heads. The Modular PLUS stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um. This submission adds three additional proximal modules, designated as size AX, BX and CX, have the same circumferential dimensions as the previously cleared AS/AL, BS/BL and CS/CL proximal modules. The differences lie in the overall length of the components. The AX module increases by 15.4mm, the BX module by 18.7mm and the CX module by 22.7mm.

    AI/ML Overview

    This document is a 510(k) summary for the Modular PLUS Revision Stem, a medical device. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device (K030971).

    No acceptance criteria or study details proving a device meets acceptance criteria are provided in the given text.

    The document discusses "Summary Nonclinical Tests" and states: "Engineering analysis shows that the bending stresses in the taper connection are less for the modified, longer modules." This is the only mention of any testing, but it does not specify acceptance criteria, test methodology, sample sizes, ground truth, or expert involvement, as this is a mechanical engineering analysis of a physical implant, not a study of an AI/ML device.

    Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document is for a traditional medical device (hip stem) and does not involve AI/ML.

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