LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251791
    Device Name
    Auxano® Wedge Fixation System
    Manufacturer
    Auxano Medical LLC
    Date Cleared
    2025-09-25

    (106 days)

    Product Code
    PLF
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K240461,K130185,K201314
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Auxano® Wedge Fixation System is intended to be used as internal bone fixation for bone fractures or osteotomies in the ankle and foot. Specific indications include:

    • Cotton (opening wedge) osteotomies of the medial cuneiform
    • Evans lengthening osteotomies

    The Auxano® Wedge Fixation System is indicated for use with ancillary plating fixation.

    The Auxano® Wedge Fixation System is not intended for spinal use.

    Device Description

    The Auxano® Wedge Fixation System (WFS) is a titanium implant that is designed to be used for internal bone fixation and angular correction of foot geometry. The implants are offered in different length x width profiles (16x11, 20x14, 18x18, 20x20, and 22x22 mm) and heights (4.50, 5.50, 6.50, 8, 10, and 12 mm) to address different anatomic locations and size variations. All implants are made from Ti-6AL-4V ELI Titanium alloy per ASTM F3001. The Auxano® Wedge Fixation System includes implants, the instruments necessary to implant them, and the tray system for transport, storage and sterilization.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1