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510(k) Data Aggregation

    K Number
    K112069
    Device Name
    RSP GLENOID BASEPLATE POROUS COATED
    Manufacturer
    ENCORE MEDICAL, L.P.
    Date Cleared
    2011-11-15

    (118 days)

    Product Code
    PHX,KWS
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K041066,K051075,K092873,K072888
    Why did this record match?
    Device Name :

    RSP GLENOID BASEPLATE POROUS COATED

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

    The Reverse Shoulder 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 Reverse Shoulder Prosthesis is a total shoulder prosthesis designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulders, the Reverse Shoulder is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into the humeral stem. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5 cancellous screw and is intended to be used with 4 peripheral screws (3.5 non-locking and/or 5.0mm locking and non-locking) for additional fixation.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving that a device meets such criteria.

    The document is a 510(k) premarket notification letter from the FDA regarding the "Encore Reverse Shoulder Prosthesis." It discusses the device's classification, indications for use, and a comparison to predicate devices, but it does not include details about:

    • Specific acceptance criteria for the device's performance.
    • A study conducted to demonstrate the device meets any performance criteria.
    • Sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document explicitly states under "Clinical Testing: None provided," indicating that clinical studies were not submitted as part of this 510(k) clearance process. The non-clinical testing mentioned (shear strength and tensile strength) is very limited and not described in enough detail to extract the requested information.

    Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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