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510(k) Data Aggregation

    K Number
    K250394
    Device Name
    Fine TTO™
    Manufacturer
    Bodycad Laboratories Inc.
    Date Cleared
    2025-10-21

    (251 days)

    Product Code
    PBF
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K241356
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fine TTO™ is a patient-specific system intended for tibial tuberosity osteotomies (TTO) in skeletally mature patients.

    The device is intended to assist in pre-operative planning and in guiding surgical instruments during the procedure, and should be used only when the anatomical landmarks required for planning can be clearly identified on the patient's radiographic images.

    Device Description

    The Fine TTO™ system is designed specifically for tibial tuberosity osteotomies to adjust the alignment and positioning of the tibia for improved knee mechanics in skeletally mature patients. This system uses advanced imaging techniques, such as X-rays and CT scans, to create precise, patient-specific surgical guides. These guides assist surgeons in accurately cutting and repositioning the tibial tuberosity, ensuring the adjustments closely match the pre-surgical planning.

    The primary function of Fine TTO™ is to facilitate precise bone cuts and ensure optimal placement according to the surgical plan, which is tailored to the patient's unique anatomy. The scientific concept behind Fine TTO™ relies on biomechanical principles of bone alignment and load distribution in the knee joint, aiming to restore the natural mechanics.

    Device design and materials:

    • Cutting Guides: Made from medical-grade polymers that are biocompatible and capable of providing the necessary rigidity and precision for bone cutting operations. These guides are designed for single use to ensure sterility and accuracy.
    • Implants (Screws): Made from titanium alloy (Ti-6Al-4V ELI), known for its strength, biocompatibility. This material is standard in orthopedic applications and helps in the fixation process post-osteotomy.

    Physical and performance characteristics:

    • The system's design ensures that the cutting guides fit precisely to the patient's bone structure, reducing the risk of intraoperative errors and improving the predictability of the surgical outcome.
    • The titanium screws used in the system provide strong, durable fixation that can withstand the mechanical forces exerted by the body weight and movement, supporting proper bone healing.
    AI/ML Overview

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