# K962808: Ilizarov External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Aug 19, 1996 after 32 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
No predicates in its family tree.
57 later devices descend from it; 8 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)
- None. The FDA summary names its predicate without a number.
- (no number) Ilizarov External Fixation System stainless steel wires and washers: named in the summary without a submission number

## Most influential descendants
- K093047: Smith & Nephew Circular Fixation System (2010), 51 descendants of its own
- 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

## Indications for use
The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities

Source page: https://510kreport.com/device/K962808
Methodology: https://510kreport.com/methodology