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510(k) Data Aggregation

    K Number
    K171004
    Device Name
    Hintermann Series H2 Total Ankle System
    Manufacturer
    Dt MedTech LLC
    Date Cleared
    2017-11-07

    (217 days)

    Product Code
    HSN
    Regulation Number
    888.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dt MedTech LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hintermann Series H2 Total Ankle Replacement (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint. The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by: · Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis) · Primary arthritis (e.g., degenerative disease) · Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant) The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present. Note: In the United States, this device is intended for cemented use only.
    Device Description
    The Hintermann Series H2 Total Ankle System includes a metal tibial component, polyethylene inlay, and metal talar component. The tibial and talar components are coated with plasma spray titanium on the bone contacting surfaces. The system is a semiconstrained device used for the indications as follows.
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