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510(k) Data Aggregation

    K Number
    K244015
    Device Name
    SuperBall-RC™
    Manufacturer
    Arcuro Medical Ltd.
    Date Cleared
    2025-02-19

    (55 days)

    Product Code
    MBI, GAT
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arcuro Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures. The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.
    Device Description
    The SuperBall-RC™ System is an all-inside, all-suture repair device. Each device includes two non-absorbable, soft suture bundles that are attached to each other (USP 1 UHMWPE) and preloaded within a needle delivery system along with the SuperBall securing element made of a braided, coreless sack. The adjustable depth delivery system insertion needle angles), enables the positioning and subsequent deployment of the two bundles under/within the soft tissue. Once placed, manipulation of the delivery system's the pulling suture (USP 3-0 Polyester Cottony II Green), thereby approximating the positioned bundles. The tightened implant is secured by the SuperBall is passed to nestle beside the deployed bundles. By pulling the SuperBall Actuating suture (USP 2-0 Polyester Tevdek II Green), a ball is formed, securing the implant in position.
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    K Number
    K223500
    Device Name
    SuperBall Meniscal Repair System
    Manufacturer
    Arcuro Medical Ltd.
    Date Cleared
    2023-08-10

    (262 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arcuro Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
    Device Description
    The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior).
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    K Number
    K180191
    Device Name
    SuperBall Meniscal Repair System
    Manufacturer
    Arcuro Medical Ltd.
    Date Cleared
    2018-06-05

    (133 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arcuro Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
    Device Description
    The SuperBall Meniscal Repair System is a suture retention device comprised of two nonabsorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. More specifically, the device consists of suture bundles, a mesh stitch, actuator suture, pulling suture, and SuperBall securing element. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior). The structure of the SuperBall is a self-locking structure enabling the SuperBall securing element to remain in its collapsed position. The SuperBall remains secure as the braided component (Mesh) is collapsed from within by pulling the Actuator Suture. The SuperBall System is provided sterile for single use only.
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