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510(k) Data Aggregation

    K Number
    K254110

    Validate with FDA (Live)

    Device Name
    DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
    Manufacturer
    MedShape, Inc.
    Date Cleared
    2026-03-18

    (89 days)

    Product Code
    HWC,HTN,JDR,JDS
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K250628,K182677,K203381,K240530,K203595,K181781,K193305,K220812
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K250628

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DynaNail Mini and DynaNail Hybrid System are indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of short bones, long bones, small fragments or large fragments in the foot and ankle.

    The DynaNail Helix is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device such as short bones, long bones, and small or large fragments in the foot and ankle.

    The DynaClip, DynaClip Forte, DynaClip Delta, DynaClip Quattro Bone Staples are indicated for

    • Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
    • Fixation of proximal tibial metaphysis osteotomy.
    • Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.
    Device Description

    The DynaNail Mini® Fusion System consists of the following components:

    • Fusion Nail
      • DynaNail Mini® Fusion Nail
      • DynaNail Hybrid™ Fusion Nail
    • End Cap
    • Screws

    The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. The Fusion Nail is manufactured from nitinol and titanium alloy (Ti6Al- 4V ELI) and is available in multiple diameters and lengths. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). The Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths.

    The DynaNail Helix® Fixation System consists of the following components:

    • DynaNail Helix Threaded Bone Fastener
    • DynaNail Helix Washer

    The DynaNail Helix Fixation System is implanted using the Ancillary Surgical Instruments. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. The DynaNail Helix Washer is manufactured from titanium alloy (Ti6Al- 4V ELI).

    The DynaClip®, DynaClip Forte®, DynaClip Delta®, DynaClip Quattro® Bone Staples are intended for internal fixation of small bones. The DynaClip Implant and Inserter comprise the DynaClip Device System. The DynaClip Implant is available in several different sizes and leg configurations.

    AI/ML Overview

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