# K163487: Ultima HA Coated Half Pins and Wire

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: Feb 13, 2017 after 63 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962823 (1996). 53 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires, Vilex, Inc. (2014) Summary page 4.

## Most influential descendants
- K243798: Orthex External Fixation System (2025), 1 descendant of its own
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System (2020), 1 descendant of its own
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own
- K252625: The Response Ortho Smart Fixator - Hexapod System (2025), 0 descendants 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/K163487
Methodology: https://510kreport.com/methodology