# K093047: Smith & Nephew Circular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 27, 2010 after 362 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962616 (1996). 51 ancestors in all.
51 later devices descend from it; 13 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 2.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 2.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 2.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 2.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 2.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 2.

## Most influential descendants
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- K143125: Orthofix True Lok Hexapod System VI.3 (2014), 26 descendants of its own
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (2015), 19 descendants of its own
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software (2011), 18 descendants of its own
- K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (2017), 11 descendants of its own

## Recalls of this device
- Jun 17, 2021 · Class II · Z-0245-2022: Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made

## Indications for use
The Smith & Nephew Circular Fixation system is intended to be used for the following indications: * Post-traumatic joint contracture which has resulted in loss of range of motion * Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction * Open and closed fracture fixation * Pseudoarthrosis of long bones * Limb lengthening by epiphyseal or metaphyseal distraction * Correction of bony or soft tissue deformities * Correction of bony or soft tissue defects * Joint arthrodesis * Infected fractures or nonunions Components in the Smith & Nephew Circular Fixation System are for single use only.

Source page: https://510kreport.com/device/K093047
Methodology: https://510kreport.com/methodology