# K260900: DYNEX® External Fixation Systems

- Pathway: 510(k) (Special)
- Applicant: Vilex, LLC
- Decided: Apr 17, 2026 after 30 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962616 (1996). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System, Vilex, LLC (2020) Summary page 5.
- K242861: TrueLok Elevate, Orthofix Srl (2024) Summary page 5.
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 5.
- K231343: Redemption Duo Hindfoot Nail System, Vilex, LLC (2024) Summary page 5.
- K250304: TITANEX Screw Systems, Vilex, LLC (2025) Summary page 5.

## Indications for use
The DYNEX® External Fixation Systems are intended for external fixation with the following indications: * Stabilization of Fractures & Osteotomy * Rear and Mid-foot Arthrodesis * Adult and Pediatric Leg Lengthening * Correction of Bony or Soft Tissue Defects or Deformities in Upper & Lower Extremities * Pseudoarthrosis or Non-Union of Long Bones The DYNEX® TRIAD - TTT Fixation System is intended for external fixation in the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities via tibial bone transport.

Source page: https://510kreport.com/device/K260900
Methodology: https://510kreport.com/methodology