510(k) · Cleared
ClearedExternal Fixation Mini Rail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 30, 2025 as substantially equivalent to K202143 (Vilex, LLC, 2020) and 1 other predicate after an 89-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Sep 30, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962823 (1996). 53 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- 2 generations backK121004 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2012
- 1 generation backK162032 Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017
- This deviceK252106 External Fixation Mini Rail SystemParagon 28, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 9 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 8 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 7 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 6 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 5 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 4 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 3 generations backK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- 2 generations backK121004 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2012
- 1 generation backK162032 Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017
- This deviceK252106 External Fixation Mini Rail SystemParagon 28, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −9 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −8 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −7 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −6 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −5 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −4 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −3 | K112254 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2011 | — |
| −2 | K121004 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2012 | — |
| −1 | K162032 | Arrowhead Mini-Rail Fixator | Arrowhead De, LLC | 2017 | — |
| 0 (this device) | K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 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? (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 |
|---|---|---|---|
| * | K202143 | Dynex MicroSummary page 6…Device Name(s) Manufacturer K-Number Dynex Micro Vilex, LLC K202143 Secondary Predicate Device: Table 1: Secondary Predicate Device Device Name(s)… | 2020 |
| * | K162032 | Arrowhead Mini-Rail FixatorSummary page 6…Device Name(s) Manufacturer K-Number Arrowhead Mini-Rail Fixator Arrowhead DE, LLC K162032 Reference Device: Table 2: Reference Device Device Name(s)… | 2017 |
| † | K232838 | Monkey RingsTM External Fixation System | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 53 ancestors have a recall of any class.
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. 2025, 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 External Fixation Mini Rail System is intended for external fixation and is indicated for stabilization of fractures and osteotomy, foot arthrodesis, adult and pediatric leg lengthening, and correction of bone deformity in the lower extremities. The External Fixation Mini Rail System is intended to be used in pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252106: External Fixation Mini Rail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252106
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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