# K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Jul 23, 2014 after 317 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: 8 generations back to K962823 (1996). 52 ancestors in all.
5 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)
- K023921: Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2003) Summary page 1.
- K033289: Modification to Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2004) Summary page 1.
- K974186: Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating, Orthofix Srl (1998) Summary page 1.
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 1.
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 1.
- K080071: Sidekick Rail Fixator, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K093550: Mini Rail External Fixator System, Small Bone Innovations, Inc. (2010) Summary page 1.
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 1.
- K112727: Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical, Medical Facets (2012)

## Most influential descendants
- K163487: Ultima HA Coated Half Pins and Wire (2017), 4 descendants of its own
- 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-toot Foot Arthrodesis 3. Adult and Pediatric Leg Lengthening 4. Correction of Bone Deformity in Upper & Lower Extremities

Source page: https://510kreport.com/device/K132820
Methodology: https://510kreport.com/methodology