# K090926: Smith & Nephew Rail System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 8, 2009 after 67 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 K802814 (1980). 7 ancestors in all.
10 later devices descend from it; 3 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)
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K970751: Heidelberg External Fixator, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 1.
- K953397: Hex-Fix Field Fixator, Smith & Nephew Richards, Inc. (1995) Summary page 1.

## Most influential descendants
- K120871: Smith & Nephew, Inc. External Fixation System Instrumentation (2012), 6 descendants of its own
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (2020), 5 descendants of its own
- K200518: Pitkar External Fixation System - Rail Mechanism (2020), 2 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own
- K241357: XT3 System (2025), 1 descendant of its own

## Indications for use
The Smith & Nephew Rail System components are intended to be used on adult or pediatric patients as required and are intended to be used for fracture fixation (open and closed); fractures and 'disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudarthrosis of long bones; limb lengthening; infected fractures or non-unions; and correction of long bone deformities. Components in the Smith & Nephew Rail System are for single use only.

Source page: https://510kreport.com/device/K090926
Methodology: https://510kreport.com/methodology