LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252733

    Validate with FDA (Live)

    Device Name
    ATLAS™ Expandable Osteotomy Wedge System
    Manufacturer
    MiRus, LLC
    Date Cleared
    2026-02-19

    (175 days)

    Product Code
    PLF
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K210800,K162241,K201314
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ATLAS™ Expandable Osteotomy Wedge System is an expandable osteotomy wedge fusion device used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle.

    The ATLAS™ Expandable Osteotomy Wedge System is intended for use with supplemental fixation for use in the foot or ankle.

    The ATLAS™ Expandable Osteotomy Wedge System is not intended for use in the spine.

    Device Description

    The ATLAS™ Expandable Osteotomy Wedge System is an expandable osteotomy wedge fusion device used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle.

    The ATLAS™ Expandable Osteotomy Wedge System consists of implants manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. Expansion mechanism components are manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273. Instrumentation are manufactured from Stainless Steel per ASTM F899.

    The ATLAS™ Expandable Osteotomy Wedge System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants (osteotomy wedges) will be provided sterile packed and are intended for single use only. The instruments will be provided non-sterile and will be steam sterilized by the end user.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1