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510(k) Data Aggregation

    K Number
    K253202

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-19

    (84 days)

    Product Code
    Regulation Number
    888.3030
    Age Range
    2 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult 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 or non-union of long bones
    • Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
    • Correction of bony or soft tissue deformity
    • Correction of segmental bony or soft tissue defects
    • Joint arthrodesis
    • Management of comminuted intra-articular fractures of the distal radius
    • Bone transport

    The Hoffmann LRF 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
    • Lisfranc dislocations
    Device Description

    The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from aluminum, carbon fiber, stainless steel, and various polymers. The system also encompasses a web application and mobile application.

    Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

    AI/ML Overview

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