510(k) · Cleared
ClearedStealth Fusion System, Model RR 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&R Medical, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Feb 7, 2005 after an 83-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Feb 7, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK043174 Stealth Fusion System, Model RR 1000R&R Medical, Inc. · 2005
- Descendant · cites it directly · 13 of its ownK052196 Vilex X-FixVilex, Inc. · 2005
- Descendant · 2 generations on · 7 of its ownK151881 X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK162033 SALVATION External Fixation SystemWright Medical · 2017
- Descendant · 3 generations on · 2 of its ownK223786 Orthex External Fixation SystemOrthoPediatrics Corp. · 2023
- Descendant · 4 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K052196Vilex X-FixVilex, Inc. · 2005 · cites it directly13descendants
- K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016 · 2 generations on7descendants
- K162033SALVATION External Fixation SystemWright Medical · 2017 · cites it directly3descendants
- K223786Orthex External Fixation SystemOrthoPediatrics Corp. · 2023 · 3 generations on2descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043174 | Stealth Fusion System, Model RR 1000 | R&R Medical, Inc. | 2005 | — |
| +1 | K052196 | Vilex X-Fix | Vilex, Inc. | 2005 | — |
| +2 | K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016 | 2 |
| +1 | K162033 | SALVATION External Fixation System | Wright Medical | 2017 | — |
| +3 | K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023 | — |
| +4 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 21.3 · 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? (2)
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 (Smith & Nephew Richards) Named without a submission number | |
| * | — | Orthofix® Modulsystem Named without a submission number |
What descends from it? (16)
See all 162 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, K052196 (Vilex, Inc., 2005) has gone furthest, with 13 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 Stealth Fusion System and its accessory components are intended to be used on adults or pediatric patients as required and are intended to be used for ankle and foot joints fusion; to stabilize fractures of foot bones; (open and closed); 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; pseudoarthrosis or non-union of foot bones; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue foot defects; joint arthrodesis; and management of comminuted intra-articular foot bone fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043174: Stealth Fusion System, Model RR 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043174
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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