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510(k) Data Aggregation

    K Number
    K253325

    Validate with FDA (Live)

    Device Name
    ZipToe™ Hammertoe Fusion System
    Manufacturer
    Toetal Solutions
    Date Cleared
    2025-12-29

    (90 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K201715,K050259
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZipToe™ Hammertoe Fusion System is indicated for interphalangeal fusion of the toes.

    Device Description

    The ZipToe™ Hammertoe Fusion System is a permanent implant designed for fixation of the proximal interphalangeal joint. The device is composed of a titanium alloy sleeve (ASTM F136) with two internally deployed nitinol claws (ASTM F2063). The implant is available in multiple sizes to accommodate varying patient anatomy. The insertion tool for the implant includes two "ripcords" that are pulled to deploy the implant's claws. The "ricord" is a surgical suture that is connected to the implant's claws through a loop; thus, once the implant in place, the ends of the suture ("ripcords") are pulled to deploy the claws. Once deployed, the claws assist in initial fixation by providing opposing compression into the bone and help minimize implant rotation.

    AI/ML Overview

    N/A

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