510(k) · Cleared
ClearedIlizarov Drill Tip Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on May 14, 2013 as substantially equivalent to K994143 (Smith & Nephew, Inc., 2000) and 4 other predicates after a 78-day review. Its family tree reaches back 10 generations to 1996. 6 later devices descend from it.
- Decided
- May 14, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K962616 (1996). 52 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- This deviceK130479 Ilizarov Drill Tip WiresSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
- Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
- Descendant · 2 generations on · 0 of its ownK253202 Hoffmann LRF SystemStryker GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK251128 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- This deviceK130479 Ilizarov Drill Tip WiresSmith & Nephew, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 2 generations on0descendants
- K253202Hoffmann LRF SystemStryker GmbH · 2025 · 2 generations on0descendants
- K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| 0 (this device) | K130479 | Ilizarov Drill Tip Wires | Smith & Nephew, Inc. | 2013 | — |
| +1 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator… | Smith & Nephew | 2020 | — |
| +2 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
| +2 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
| +2 | K253202 | Hoffmann LRF System | Stryker GmbH | 2025 | — |
| +2 | K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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 21.4 · 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? (5)
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 |
|---|---|---|---|
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 2…ivalence is based on identical or very similar design features, overall indications for use, and raw material composition. . Smith & Nephew Smooth and Olive Wires - K994143 a llizarov Drill Tip Wires - K093047 * Richards Transfixation Wires - K870961 * Smith & Nephew Drill Tip Kirschner Wi… | 2000 |
| * | K093047 | Smith & Nephew Circular Fixation SystemSummary page 2…milar design features, overall indications for use, and raw material composition. . Smith & Nephew Smooth and Olive Wires - K994143 a llizarov Drill Tip Wires - K093047 * Richards Transfixation Wires - K870961 * Smith & Nephew Drill Tip Kirschner Wires (K-wires) - K090675 * Ilizarov Ex… | 2010 |
| * | K870961 | Richards External Fixation SystemSummary page 2…r use, and raw material composition. . Smith & Nephew Smooth and Olive Wires - K994143 a llizarov Drill Tip Wires - K093047 * Richards Transfixation Wires - K870961 * Smith & Nephew Drill Tip Kirschner Wires (K-wires) - K090675 * Ilizarov External Fixation System - Titanium Wires and W… | 1987 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 2…nd Olive Wires - K994143 a llizarov Drill Tip Wires - K093047 * Richards Transfixation Wires - K870961 * Smith & Nephew Drill Tip Kirschner Wires (K-wires) - K090675 * Ilizarov External Fixation System - Titanium Wires and Washers - K962808 Preclinical Testing: To further support a deter… | 2009 |
| * | K962808 | Ilizarov External Fixation SystemSummary page 2…s Transfixation Wires - K870961 * Smith & Nephew Drill Tip Kirschner Wires (K-wires) - K090675 * Ilizarov External Fixation System - Titanium Wires and Washers - K962808 Preclinical Testing: To further support a determination of substantial equivalence, pre-clinical bench testing was conducted o… | 1996 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV… | 2020 | 5 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 15 of the 52 ancestors have a recall of any class.
- Of its descendants, K201253 (Smith & Nephew, 2020) has gone furthest, with 5 descendants of its own.
- 18 other devices also cite its predicate K994143.
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. 2013, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130479: Ilizarov Drill Tip Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130479
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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