510(k) · Cleared
ClearedEbi X Fix Dynafix Mini External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 1, 1997 after a 67-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.
- Decided
- Apr 1, 1997
- Review
- 67 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 5 citing it directly.
- This deviceK970290 Ebi X Fix Dynafix Mini External Fixation SystemEbi, L.P. · 1997
- Descendant · cites it directly · 13 of its ownK052196 Vilex X-FixVilex, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
- Descendant · 2 generations on · 7 of its ownK151881 X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK100137 Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010
- Descendant · 2 generations on · 4 of its ownK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K052196Vilex X-FixVilex, Inc. · 2005 · cites it directly13descendants
- K052005R&R External Fixation SystemR&R Medical, Inc. · 2005 · cites it directly11descendants
- K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016 · 2 generations on7descendants
- K100137Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010 · 2 generations on6descendants
- K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970290 | Ebi X Fix Dynafix Mini External Fixation System | Ebi, L.P. | 1997 | — |
| +1 | K052196 | Vilex X-Fix | Vilex, Inc. | 2005 | — |
| +1 | K052005 | R&R External Fixation System | R&R Medical, Inc. | 2005 | — |
| +2 | K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016 | 2 |
| +2 | K100137 | Sidekick Circular Fixator System: Struts and Hinges | Wrightmedicaltechnologyinc | 2010 | — |
| +2 | K153635 | SALVATION (R) External Fixation System | Wrightmedicaltechnologyinc | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | — | Orthofix® Mini Fixator Named without a submission number | |
| * | — | Orthofix® Mini Lengthener Named without a submission number | |
| * | — | Synthes Mini External Fixator Named without a submission number | |
| * | — | Hoffman Mini External Fixator Named without a submission number |
What descends from it? (28)
See all 285 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 EBI X FIX™ DynaFix® Mini External Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
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/K970290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970290: Ebi X Fix Dynafix Mini External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970290
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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