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510(k) Data Aggregation

    K Number
    K253566

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-12

    (115 days)

    Product Code
    Regulation Number
    888.3020
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Affixus Retrograde Femoral Nailing System is indicated for:

    • Compound and simple shaft fractures
    • Proximal, metaphyseal and distal shaft fractures
    • Segmental fractures
    • Closed supracondylar fractures
    • Severely comminuted supracondylar fractures with articular involvement
    • Fractures involving femoral condyles
    • Comminuted fractures
    • Fractures involving osteopenic and osteoporotic bone
    • Pathological fractures
    • Fractures with bone loss
    • Pseudoarthrosis, non union, and mal union
    • Periprosthetic fractures
    • Poly trauma patients
    Device Description

    The Affixus Retrograde Femoral Nailing System is part of the Affixus long bone nailing platform, designed for the treatment of a wide range of femoral fractures, from simple to complex. The system provides multiple locking options to support fracture stabilization and healing. All nails are made of type II anodized Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

    AI/ML Overview

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