510(k) · Cleared
ClearedMini Rail External Fixator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Small Bone Innovations, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 7, 2010 as substantially equivalent to K964094 (Ferguson Medical, 1996) after a 51-day review. Its family tree reaches back 2 generations to 1986. 8 later devices descend from it.
- Decided
- Jan 7, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861766 (1986). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 1 generation backK964094 MinifixFerguson Medical · 1996
- This deviceK093550 Mini Rail External Fixator SystemSmall Bone Innovations, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK163487 Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
- Descendant · 2 generations on · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK260900 DYNEX® External Fixation SystemsVilex, LLC · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · cites it directly5descendants
- K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017 · 2 generations on4descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · 2 generations on1descendant
- K260900DYNEX® External Fixation SystemsVilex, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −1 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| 0 (this device) | K093550 | Mini Rail External Fixator System | Small Bone Innovations, Inc. | 2010 | — |
| +1 | K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | Vilex, Inc. | 2014 | — |
| +2 | K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017 | — |
| +3 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
| +2 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | — |
| +3 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K964094 | MinifixSummary page 1…medical grade aluminum and stainless steel. Predicate Devices: The modified device is equivalent to the cleared SBi (formerly Fixano) MiniFIX External Fixator K964094. /o'Q I Ce DEPARTMENT OF HEALTH &HUMAN SERVICES… | 1996 |
What descends from it? (8)
3 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 24 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132820 (Vilex, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K964094.
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. 2010, 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?
The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093550: Mini Rail External Fixator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093550
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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