510(k) · Cleared
ClearedVilex X-Fix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 22, 2005 as substantially equivalent to K043174 (R&R Medical, Inc., 2005) and 2 other predicates after a 103-day review. Its family tree reaches back 2 generations to 1983. 13 later devices descend from it.
- Decided
- Nov 22, 2005
- Review
- 103 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K831576 (1983). 4 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 1 generation backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- This deviceK052196 Vilex X-FixVilex, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK151881 X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK223786 Orthex External Fixation SystemOrthoPediatrics Corp. · 2023
- Descendant · 3 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
- Descendant · cites it directly · 1 of its ownK202143 Dynex MicroVilex, LLC · 2020
- Descendant · cites it directly · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016 · cites it directly7descendants
- K223786Orthex External Fixation SystemOrthoPediatrics Corp. · 2023 · 2 generations on2descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
- K202143Dynex MicroVilex, LLC · 2020 · cites it directly1descendant
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −1 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| 0 (this device) | K052196 | Vilex X-Fix | Vilex, Inc. | 2005 | — |
| +1 | K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016 | 2 |
| +2 | K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023 | — |
| +3 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
| +1 | K202143 | Dynex Micro | Vilex, LLC | 2020 | — |
| +1 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K043174 | Stealth Fusion System, Model RR 1000 | 2005 |
| * | K955848 | Orthofix ModulsystemSummary page 1…030, CFR-21 888.3040 Device Class I Classification Panel Orthopedics Predicate Devices: K043'174 R&R Medical, Inc. K955848 Orthofix K970290 EBI Common/Generic External Ring Fixation Device Trade… | 1996 |
| * | K970290 | Ebi X Fix Dynafix Mini External Fixation SystemSummary page 1…I Classification Panel Orthopedics Predicate Devices: K043'174 R&R Medical, Inc. K955848 Orthofix K970290 EBI Common/Generic External Ring Fixation Device Trade Name Vilex External Fixation System… | 1997 |
What descends from it? (13)
See all 135 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151881 (Vilex IN Tennessee, Inc., 2016) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K043174.
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 Vilex X-Fix is intended for external fixation with the following indications:
1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052196: Vilex X-Fix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052196
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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