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    K Number
    K253345
    Device Name
    JARVIS Diaphyseal Stem Standard
    Manufacturer
    FH Industrie
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    PHX,HSD,KWS
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K202024,K093591,K112193,K150568
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The prostheses from FH Industrie are designed for specific indications such as:

    SIMPLE HUMERAL PROSTHESIS

    • Humeral head necrosis without injury to the glenoid cavity.
    • Extensive humeral head cartilage damage without injury to the glenoid cavity
    • Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
    • Rheumatoid polyarthritis with thin rotator cuff.
    • Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

    TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH PEGS)

    • Centred glenohumeral osteoarthritis with functional rotator cuff
    • Rheumatoid polyarthritis with functional rotator cuff
    • Post-traumatic sequela, functional rotator cuff with glenoid injury.

    TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

    • Centred glenohumeral osteoarthritis
    • Rheumatoid polyarthritis
    • Post-traumatic sequela with glenoid injury
    • Revision for glenoid loosening
    • Glenoid bone loss, where bone graft is needed

    A functional rotator cuff is necessary to use this device

    REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
    The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

    For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.

    At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

    Device Description

    The JARVIS Diaphyseal Stem Standard is an extension of humeral stem range of the Arrow prosthesis. The JARVIS Diaphyseal Stem Standard is intended to be used with the Metaphyseal component of the modular ARROW Short Stem device (K202024). The JARVIS Diaphyseal Stem Standard is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3.

    AI/ML Overview

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