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510(k) Data Aggregation

    K Number
    K253517

    Validate with FDA (Live)

    Device Name
    Reselute Tibial Nail
    Manufacturer
    Reselute, Inc.
    Date Cleared
    2026-03-10

    (118 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K143245,K230761
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Reselute Traditional Tibial Intramedullary Nail is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions and non-unions.

    Device Description

    The Reselute Tibial Intramedullary Nail System is a single use intramedullary device for the fixation, correction, or stabilization of the tibia. The Reselute Tibial Intramedullary Nail implant system includes a tibial nail offered at various diameters and lengths to accommodate a range of patient anatomies, cross-locking screws to prevent movement of the nail relative to the bone fragments, and optional endcaps for preventing proximal bone ingrowth. Each implant component is manufactured from titanium alloy (Ti-6Al-4V), which conforms to ASTM F136-13 for medical implants.

    AI/ML Overview

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