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510(k) Data Aggregation

    K Number
    K211385
    Device Name
    KeriFlex® MCP and PIP Finger Joint Prostheses
    Manufacturer
    Keri Medical SA
    Date Cleared
    2022-07-27

    (449 days)

    Product Code
    KYJ
    Regulation Number
    888.3230
    Why did this record match?
    Applicant Name (Manufacturer) :

    Keri Medical SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative or traumatic arthritis.
    Device Description
    The KeriFlex® Finger Joint Prostheses are flexible, one-piece, hinged silicone elastomer implants designed to be implanted across the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. The KeriFlex® Finger Joint Prostheses are single-use devices indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative, or traumatic arthritis. The KeriFlex® Finger Prostheses are provided sterile and are intended to be single use. The associated instruments include: - Patterns to be used prior to the bone cut to identify the resection level and to identify the definitive implant. - Starter (awl) to help the surgeon prepare the implantation site. - Rasps to help the surgeon prepare the implantation site. - Sterilization tray, lid, insert and rack which protect the instruments during transportation and sterilization.
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