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510(k) Data Aggregation

    K Number
    K051075
    Device Name
    ENCORE REVERSE SHOULDER PROSTHESIS
    Manufacturer
    ENCORE MEDICAL, L.P.
    Date Cleared
    2005-05-27

    (30 days)

    Product Code
    PHX,KWS
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K041066
    Predicate For
    K052086,K063569,K072804,K080642,K092873,K100741,K110599,K111061,K112069,K131559,K141006,K151293,K213459,K233481,K251184
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Encore Reverse Shoulder Prosthesis® (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

    The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

    The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

    Device Description

    The Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, in operation our, half, half hand rotator cuff are irreparable. Unlike traditional total shoulders, the RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. buooplate, and this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws. The glenoid baseplate is intended for cementless a glondia baouplate, and bon of screws for fixation. The humeral stem is intended for cemented use only. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the Encore Reverse Shoulder Prosthesis (RSP), stating its indications for use and substantial equivalence to a previously cleared device.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The information about the device's technical specifications and the regulatory clearance process is present, but not the performance evaluation data you're asking for.

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