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    K Number
    K250628
    Device Name
    DynaNail TTC Fusion System
    Manufacturer
    MedShape, Inc.
    Date Cleared
    2025-09-12

    (193 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K251850,K221031,K171376
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K251850, K221031

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

    The DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal fusions:

    • Post-traumatic and degenerative arthritis.
    • Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
    • Revision after failed ankle arthrodesis with subtalar involvement.
    • Failed total ankle arthroplasty.
    • Non-union ankle arthrodesis.
    • Rheumatoid hindfoot.
    • Absent Talus (requiring tibiocalcaneal arthrodesis).
    • Avascular necrosis of the talus.
    • Neuroarthropathy or neuropathic ankle deformity.
    • Neuromuscular disease and severe deformity.
    • Osteoarthritis.
    • Charcot Foot.
    • Previously infected arthrosis, second degree.
    Device Description

    The DynaNail TTC Fusion System consists of the following components: the DynaNail TTC Fusion Nail, DynaNail End Cap, DynaNail Screws, and the DynaNail Deployment Frame. The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are implanted into the medullary canal of the tibia, talus and calcaneus using the DynaNail Deployment Frame and Ancillary Surgical Instruments.

    The DynaNail TTC Fusion Nail is manufactured from nitinol and titanium alloy (Ti 6Al-4V ELI) and is available in multiple diameters and lengths. The DynaNail End Cap is manufactured from titanium alloy (Ti-6AI-4V ELI). The DynaNail Screws are manufactured from titanium alloy (Ti 6Al- 4V ELI) and are available in a range of lengths.

    AI/ML Overview

    N/A

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