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510(k) Data Aggregation

    K Number
    K201315
    Device Name
    PERFORM Humeral System – Stem
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2020-09-11

    (116 days)

    Product Code
    PAO, HSD, KWS, KWT, PHX
    Regulation Number
    888.3660
    Why did this record match?
    Product Code :

    PAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In Anatomic: The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System – Stem is indicated for use as a replacement of shoulder joints disabled by: - Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis . - Correction of functional deformity - Post-traumatic arthritis 0 - o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy. All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty. In Reverse: The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following: - o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - Pseudoparalysis or anterior superior escape ● - Rotator cuff tear arthropathy - Correction of functional deformity - Post-traumatic arthritis - o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle. All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
    Device Description
    The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty. The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.
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