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510(k) Data Aggregation

    K Number
    K201072
    Device Name
    Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
    Manufacturer
    Ensemble Orthopedics, LLC
    Date Cleared
    2020-12-02

    (224 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ensemble Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
    Device Description
    The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels. A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.
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