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510(k) Data Aggregation

    K Number
    K241180
    Device Name
    Consensus Knee System with TiNbN
    Date Cleared
    2025-01-14

    (260 days)

    Product Code
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shalby Advanced Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use are: A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis B. Failed osteotomy or unicompartmental replacements C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement E. The porous coated (CoCr beads with Titanium) components may be used with or without cement
    Device Description
    The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants. The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.
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