# K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Aug 24, 2020 after 31 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: 12 generations back to K962616 (1996). 104 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052196: Vilex X-Fix, Vilex, Inc. (2005) Summary page 4.
- K151881: X-Fix Line Additions, Vilex IN Tennessee, Inc. (2016) Summary page 4.
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires, Vilex, Inc. (2014) Summary page 4.
- K163487: Ultima HA Coated Half Pins and Wire, Vilex IN Tennessee, Inc. (2017) Summary page 4.

## Most influential descendants
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own

## Indications for use
The Vilex External Fixation System is intended for external fixation with the following indications: Stabilization of Fractures & Osteotomy Rear and Mid-foot Arthrodesis Adult and Pediatric Leg Lengthening Correction of Bone Deformity in Upper & Lower Extremities

Source page: https://510kreport.com/device/K202054
Methodology: https://510kreport.com/methodology