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510(k) Data Aggregation

    K Number
    K192365
    Device Name
    Shoulder Innovations Total Shoulder System
    Manufacturer
    Shoulder Innovations Inc
    Date Cleared
    2019-11-29

    (91 days)

    Product Code
    KWT, HSD, KWS, MBF
    Regulation Number
    888.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shoulder Innovations Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatic disease of the glenohumeral joint; 2. avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
    Device Description
    The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems. The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.
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    K Number
    K173824
    Device Name
    Humeral Short Stem System
    Manufacturer
    Shoulder Innovations Inc
    Date Cleared
    2018-10-23

    (309 days)

    Product Code
    MBF, HSD, KWS, KWT
    Regulation Number
    888.3670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shoulder Innovations Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; 2. avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
    Device Description
    The Shoulder Innovations Humeral Short Stem consists of modular humeral stems and heads and articulates with the Shoulder Innovations glenoid component (K111596). The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.
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