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510(k) Data Aggregation

    K Number
    K111596
    Device Name
    TOTAL SHOULDER SYSTEM
    Manufacturer
    SHOULDER INNOVATIONS, LLC
    Date Cleared
    2011-07-05

    (27 days)

    Product Code
    KWS, HSD, KWT
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOULDER INNOVATIONS, LLC

    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: - significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - united humeral head fractures of long duration: . - . irreducible 3- and 4-part proximal humeral fractures: - 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 components are intended for cemented fixation only; the humeral stem mav be implanted by press-fit or cement fixation.
    Device Description
    The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems. The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-pegged and keeled design and are intended for cemented fixation only.
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    K Number
    K110905
    Device Name
    TOTAL SHOULDER SYSTEM
    Manufacturer
    SHOULDER INNOVATIONS, LLC
    Date Cleared
    2011-05-24

    (54 days)

    Product Code
    KWS, HSD, KWT
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOULDER INNOVATIONS, LLC

    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: - significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - united humeral head fractures of long duration; - irreducible 3- and 4-part proximal humeral fractures; - 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, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems. The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-peqged and keeled design and are intended for cemented fixation only.
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    K Number
    K102670
    Device Name
    TOTAL SHOULDER SYSTEM
    Manufacturer
    SHOULDER INNOVATIONS, LLC
    Date Cleared
    2011-01-24

    (130 days)

    Product Code
    KWS, HSD, KWT
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOULDER INNOVATIONS, LLC

    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: - significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - united humeral head fractures of long duration; - irreducible 3- and 4-part proximal humeral fractures; - 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, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems. The glenoid component is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid is a multi-pegged design and intended for cemented fixation only.
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