# K052196: Vilex X-Fix

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Nov 22, 2005 after 103 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: 2 generations back to K831576 (1983). 4 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043174: Stealth Fusion System, Model RR 1000, R&R Medical, Inc. (2005)
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 1.
- K970290: Ebi X Fix Dynafix Mini External Fixation System, Ebi, L.P. (1997) Summary page 1.

## Most influential descendants
- K151881: X-Fix Line Additions (2016), 7 descendants of its own
- K223786: Orthex External Fixation System (2023), 2 descendants of its own
- K243798: Orthex External Fixation System (2025), 1 descendant of its own
- K202143: Dynex Micro (2020), 1 descendant of its own
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System (2020), 1 descendant of its own

## Indications for use
The Vilex X-Fix is intended for external fixation with the following indications: 1. Stabilization of Fractures & Osteotomy 2. Rear & Mid-foot Foot Arthrodesis 3. Adult and Pediatric Leg Lengthening 4. Correction of Bone Deformity in Upper & Lower Extremities.

Source page: https://510kreport.com/device/K052196
Methodology: https://510kreport.com/methodology