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510(k) Data Aggregation

    K Number
    K252567

    Validate with FDA (Live)

    Date Cleared
    2026-01-15

    (154 days)

    Product Code
    Regulation Number
    888.3660
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K203755

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

    • Severe arthropathy with a grossly deficient rotator cuff;
    • Previously failed joint replacement with a grossly deficient rotator cuff;
    • Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
    • Bone defect in proximal humerus;
    • Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
    • Inflammatory arthritis including rheumatoid arthritis;
    • Correction of functional deformity.

    The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

    All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

    Device Description

    The AltiVate Reverse® ADLC Glenosphere is a line extension to the existing Reverse Shoulder Prosthesis® (RSP) Glenosphere for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of glenospheres manufactured from titanium alloy (Ti-6Al-4V) and coated on the articulating surface with amorphous diamond-like carbon (ADLC).

    AI/ML Overview

    N/A

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