510(k) · Cleared
ClearedE-Z Frame External Surgical Support Boot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signal Medical Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Feb 11, 2005 after a 74-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK043289 E-Z Frame External Surgical Support BootSignal Medical Corp. · 2005
- Descendant · cites it directly · 7 of its ownK130044 Sidekick EZ Frame External Fixation SystemWrightmedicaltechnologyinc · 2013
- Descendant · 2 generations on · 4 of its ownK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
- Descendant · 3 generations on · 3 of its ownK162033 SALVATION External Fixation SystemWright Medical · 2017
- Descendant · 2 generations on · 1 of its ownK180832 SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018
- Descendant · 3 generations on · 0 of its ownK200343 FusionFrame Ring Lock SystemGlw Medical Innovation · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130044Sidekick EZ Frame External Fixation SystemWrightmedicaltechnologyinc · 2013 · cites it directly7descendants
- K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016 · 2 generations on4descendants
- K162033SALVATION External Fixation SystemWright Medical · 2017 · 3 generations on3descendants
- K180832SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018 · 2 generations on1descendant
- K200343FusionFrame Ring Lock SystemGlw Medical Innovation · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043289 | E-Z Frame External Surgical Support Boot | Signal Medical Corp. | 2005 | — |
| +1 | K130044 | Sidekick EZ Frame External Fixation System | Wrightmedicaltechnologyinc | 2013 | — |
| +2 | K153635 | SALVATION (R) External Fixation System | Wrightmedicaltechnologyinc | 2016 | — |
| +3 | K162033 | SALVATION External Fixation System | Wright Medical | 2017 | — |
| +2 | K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2018 | — |
| +3 | K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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 21.3 · 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?
The FDA summary names no predicate by number.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K130044 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 7 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?
Triple arthrodesis
Isolated rearfoot arthrodesis
Midfoot arthrodesis
comminuted trauma
Diabetic Charcot reconstruction
Most foot pathology not requiring fixation above the ankle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043289: E-Z Frame External Surgical Support Boot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043289
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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