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510(k) Data Aggregation

    K Number
    K203375
    Device Name
    OVOMotion Reverse Shoulder Arthroplasty System
    Manufacturer
    Arthrosurface Inc.
    Date Cleared
    2021-06-24

    (220 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arthrosurface Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and glenoid vault should be of sufficient bone stock to support loading. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically suited to receive the selected implants. Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use.
    Device Description
    The OVOMotion Reverse Shoulder Arthroplasty System (RSA) is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The humeral side of the system is comprised of a humeral cup and humeral insert which are attached to the Arthrosurface TSA Humeral Stem using an adapter ring. The glenosphere is implanted with the GlenoidBaseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.
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    K Number
    K142942
    Device Name
    HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
    Manufacturer
    ARTHROSURFACE INC.
    Date Cleared
    2014-12-19

    (66 days)

    Product Code
    HSD
    Regulation Number
    888.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTHROSURFACE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.
    Device Description
    The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
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