# K151881: X-Fix Line Additions

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: Mar 24, 2016 after 259 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 60 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software, Smith & Nephew, Inc. (2011) Summary page 4.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 4.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 4.
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex), Orthofix Srl (2014) Summary page 4.
- K052196: Vilex X-Fix, Vilex, Inc. (2005) Summary page 4.

## Most influential descendants
- K223786: Orthex External Fixation System (2023), 2 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

## Recalls of this device
- Sep 12, 2022 · Class II · Z-0277-2023: Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
- Jun 29, 2022 · Class II · Z-1678-2022: Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could resul

## Indications for use
The Vilex X-Fix is intended for external fixation with the following indications: 1. Stabilization of Fractures & Osteotomy 2. Adult and Pediatric Leg Lengthening 3. Correction of Bone Deformity in Upper & Lower Extremities The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.

Source page: https://510kreport.com/device/K151881
Methodology: https://510kreport.com/methodology