# K130479: Ilizarov Drill Tip Wires

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 14, 2013 after 78 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: 10 generations back to K962616 (1996). 52 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 59 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 2.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 2.
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 2.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 2.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 2.

## Most influential descendants
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (2020), 5 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own
- K253202: Hoffmann LRF System (2025), 0 descendants of its own
- K251128: Extremity Medical External Fixation System (2025), 0 descendants of its own

## Indications for use
Ilizarov Drill Tip Wires are 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 Ilizarov Drill Tip Wires are for single use only.

Source page: https://510kreport.com/device/K130479
Methodology: https://510kreport.com/methodology