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510(k) Data Aggregation

    K Number
    K253291

    Validate with FDA (Live)

    Device Name
    Excelsior System
    Manufacturer
    Date Cleared
    2026-01-20

    (113 days)

    Product Code
    Regulation Number
    888.3030
    Age Range
    2 - 21
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Excelsior External Fixation System is indicated for adult and pediatric (greater than 2 through 21 years of age) patients for the treatment and fixation of:

    • Open and closed fractures
    • Post-traumatic joint contracture which has resulted in loss of range of motion
    • Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
    • Pseudoarthrosis, infected union, non-union, or malunion of long bones
    • Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
    • Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
    • Correction of segmental bony or soft tissue defects
    • Joint arthrodesis
    • Management of comminuted intra-articular fractures
    • Bone transport

    The Excelsior External Fixation System is indicated in adults for:

    • Osteotomy
    • Revision procedure where other treatments or devices have been unsuccessful
    • Bone reconstruction procedures
    • Fusions and replantations of the foot
    • Charcot foot reconstruction
    • Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
    • Lisfranc dislocations
    • Ankle distraction (arthrodiastasis)
    • Septic fusion

    The Excelsior Translation Device is not intended for weight bearing applications. Patients must remain non weight bearing on the Excelsior External Fixation frame when the Excelsior Translation Device is used for transport applications.

    Device Description

    The Blue Ocean Global Excelsior System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, telescoping struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. Special wrenches and accessories are included for the proper assembly of the components. The system is manufactured from stainless steel, aluminum, and titanium.

    AI/ML Overview

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