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510(k) Data Aggregation

    K Number
    K250338

    Validate with FDA (Live)

    Date Cleared
    2025-10-31

    (267 days)

    Product Code
    Regulation Number
    888.3660
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff 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 stems are intended for cemented or cementless use.

    The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

    The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. 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 short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

    Device Description

    The MSS - Humeral reverse liners extension is a Medacta Shoulder System line extension aiming to include the following new implants:

    • Humeral reverse liners made of Vitamin E Highly Crosslinked polyethylene (E-Cross); and
    • Humeral reverse constrained liners available both in Highly Crosslinked Polyethylene (HCPE) and Vitamin E Highly Crosslinked polyethylene (E-Cross).

    The MSS - Humeral reverse liners extension implants are intended to be used in the reverse configuration only, in order to replace the humeral side of the gleno-humeral joint. They are available in 4 articular surface diameters and 3 heights. The subject MSS - Humeral reverse liners have been designed to be coupled with Medacta Shoulder System humeral reverse metaphysis and to provide an articular surface for the glenosphere.

    The subject liners are implantable devices provided individually packed, sterile and single-use.

    AI/ML Overview

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