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510(k) Data Aggregation

    K Number
    K252516

    Validate with FDA (Live)

    Device Name
    N22 EZ Glenosphere
    Manufacturer
    Shoulder Innovations, Inc.
    Date Cleared
    2026-01-15

    (157 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K213856,K210533,K173824
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InSet Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

    The InSet Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.

    N22 EZ Glenosphere made of Titanium is indicated for patients with a suspected sensitivity to the constituents of CoCr alloy that complies with ASTM F75. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Cobalt Alloy Glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to the constituents of CoCr alloy.

    Device Description

    The proposed N22 EZ Glenosphere is manufactured from titanium alloy (Ti-6Al-4V) per F136 featuring a nitrogen ion implantation surface hardening treatment. It is designed for use with the InSet™ Reverse Total Shoulder System components cleared under K210533, maintaining the same dimensional specifications as the cleared CoCr Glenospheres (K210533), with modifications including increased articular surface roughness and a radiused distal end on the male Morse taper. The glenosphere-baseplate construct and humeral assembly mirror those of the predicate device, utilizing a central compression screw with peripheral screws for baseplate fixation and compatible humeral stems (K173824), which allow for press-fit or cemented use. All associated components (humeral stem, tray, baseplate, screws) are made from Ti-6Al-4V per ASTM F136, with porous titanium coating (ASTM F67) on the humeral stem and baseplate.

    AI/ML Overview

    N/A

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