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510(k) Data Aggregation

    K Number
    K250037
    Device Name
    Incompass Total Ankle System
    Manufacturer
    Wright Medical Technology, Inc. (Stryker)
    Date Cleared
    2025-06-20

    (163 days)

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

    Wright Medical Technology, Inc. (Stryker)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
    Device Description
    Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments. Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.
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