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510(k) Data Aggregation

    K Number
    K252025

    Validate with FDA (Live)

    Device Name
    Active Intramedullary (AIM) Tibial Nail System
    Manufacturer
    Satori Orthopaedics, Inc.
    Date Cleared
    2026-03-04

    (247 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K170972,K083459,K113828,K082770,K202099
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Active Intramedullary (AIM) Tibial Nail System is indicated for the following:

    • Open or closed fractures of the tibial shaft
    • Proximal or distal tibial shaft fractures
    • Tibial shaft fractures including transverse, short oblique, long oblique, and comminuted fracture patterns
    • Tibial non-unions and malunions
    • Pathologic and/or impending fractures
    Device Description

    The AIM Tibial Nail System is a tibial intramedullary fixation rod designed to be implanted proximally and distally to a fracture line. The system consists of the Intramedullary (IM) Nail and Interlocking Screws. The IM Nail is made from titanium alloy and includes an internal compression spring for compression force/axial movement.

    AI/ML Overview

    N/A

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