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510(k) Data Aggregation

    K Number
    K252044
    Date Cleared
    2025-10-24

    (116 days)

    Product Code
    Regulation Number
    888.3565
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K123486, K182346, K212761, K963101, K161569, K093746

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    General Total Knee Arthroplasty (TKR) Indications:

    • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
    • Post-traumatic loss of knee joint configuration and function.
    • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
    • Revision of previous unsuccessful knee replacement or other procedure.
    • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques

    The Triathlon® Gold Femoral Components are indicated for both uncemented and cemented use.

    Device Description

    The Triathlon® Total Knee System is a total knee prosthesis designed to resurface the articulating surface of the femoral and tibial bones. In a total knee replacement, Triathlon® Gold Femoral Components are intended to replace the articulating surface of the distal femur and articulate against an articular surface of the tibial component as well as an optional patellar component. Triathlon® Gold Femoral Components are additively manufactured from Ti-6Al-4V powder, using Electron Beam Melting (EBM) technology, and then fully coated with titanium nitride (TiN), using Physical Vapor Deposition (PVD). In addition to TiN coating, the bone cut facing surfaces of these femoral components contain the Tritanium® porous structure. Indicated for both uncemented and cemented use, the subject femoral components are provided in right and left configurations and eight proportional sizes (sizes 1-8) for a total of 16 unique components to accommodate differences in patient anatomy. The subject femoral components are sterile, single use devices.

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