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510(k) Data Aggregation

    K Number
    K222589
    Device Name
    Flexible Suturing System with Anchors (FSSA)
    Date Cleared
    2023-01-26

    (153 days)

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

    Integrity Orthopaedics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flexible Suturing System with Anchors (FSSA) is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
    Device Description
    The Flexible Suturing System with Anchors (FSSA) includes anchors, a pre-strung single common repair suture serially connecting the anchors in an array and an individual locking suture associated with each anchor (except the first anchor in the array) for selectively locking the repair suture relative to each anchor after tensioning the repair suture to form a tensioned stitch with a just prior implanted anchor in the array. The implanted array of anchors with a continuous set of anchor-to-anchor single suture stitches creates a seam-like attachment akin to a sewing machine construct. Each anchor of the FSSA is a monolithic injection molded body. An ancillary delivery instrument is utilized to create a bone hole and insert each anchor.
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