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    K Number
    K030971
    Device Name
    MODIFICATION TO MODULAR PLUS REVISION STEM
    Manufacturer
    PLUS ORTHOPEDICS
    Date Cleared
    2003-04-24

    (27 days)

    Product Code
    LWJ
    Regulation Number
    888.3360
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K994126
    Predicate For
    K032709,K123598
    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 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 system that consists of a distal anchorage module and proximal revision module, connected by a multistage tapered coupling, secured by a cylindrical screw.

    A total of 96 different anatomically-matched stems can be combined for the left and right hips by using 24 distal and 6 proximal modules.

    The Modular PLUS stem system 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.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device and, as such, does not contain information about acceptance criteria or a study proving the device meets said criteria.

    The 510(k) summary (Input {0}) and the FDA clearance letter (Input {1} to {3}) are primarily concerned with demonstrating "substantial equivalence" to a predicate device already on the market, rather than presenting efficacy study results against predefined acceptance criteria for the new device.

    Therefore, I cannot extract the requested information from the provided text.

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