510(k) · Cleared
ClearedIlizarov External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Aug 19, 1996 after a 32-day review. The FDA summary names its predicate without a number. 57 later devices descend from it.
- Decided
- Aug 19, 1996
- Review
- 32 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 8 citing it directly.
- This deviceK962808 Ilizarov External Fixation SystemSmith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 51 of its ownK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- Descendant · 3 generations on · 26 of its ownK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- Descendant · 4 generations on · 19 of its ownK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- Descendant · 2 generations on · 18 of its ownK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · cites it directly51descendants
- K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · 2 generations on32descendants
- K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014 · 3 generations on26descendants
- K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015 · 4 generations on19descendants
- K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962808 | Ilizarov External Fixation System | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| +2 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| +3 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| +4 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| +2 | K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software | Smith & Nephew, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ilizarov External Fixation System stainless steel wires and washers Named without a submission number |
What descends from it? (57)
See all 578 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093047 | Smith & Nephew Circular Fixation System | 2010 | 51 |
| K130479 | Ilizarov Drill Tip Wires | 2013 | 6 |
| K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | 2012 | 6 |
| K190069 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | 2019 | 3 |
| K012634 | Reprocessed External Fixation Device | 2002 | 1 |
| K200343 | FusionFrame Ring Lock System | 2020 | 0 |
| K093753 | Mdpo Frame System | 2010 | 0 |
| K032169 | Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring) | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093047 (Smith & Nephew, Inc., 2010) has gone furthest, with 51 descendants of its own.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
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…
Read the full statement (110 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962808: Ilizarov External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962808
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026