510(k) · Cleared
ClearedArrowhead Mini-Rail Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrowhead De, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Feb 21, 2017 as substantially equivalent to K080071 (Wrightmedicaltechnologyinc, 2008) and 2 other predicates after a 214-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Feb 21, 2017
- Review
- 214 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962823 (1996). 46 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 2 generations backK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- 1 generation backK121004 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2012
- This deviceK162032 Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017
- Descendant · cites it directly · 0 of its ownK252106 External Fixation Mini Rail SystemParagon 28, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 8 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 7 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 6 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 5 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 4 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 3 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 2 generations backK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- 1 generation backK121004 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2012
- This deviceK162032 Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K252106External Fixation Mini Rail SystemParagon 28, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −8 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −7 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −6 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −5 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −3 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −2 | K112254 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2011 | — |
| −1 | K121004 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2012 | — |
| 0 (this device) | K162032 | Arrowhead Mini-Rail Fixator | Arrowhead De, LLC | 2017 | — |
| +1 | 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 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K080071 | Sidekick Rail FixatorSummary page 5…162032 Page 2 of 2 Predicate SIDEKICK Rail Fixator K080071 Devices Apex Kirschner Wires and Steinmann Pins K121004 ST.A.R.90 F4 External Fixation Screws… | 2008 |
| * | K121004 | Apex Kirschner Wires and Steinmann PinsSummary page 5…Page 2 of 2 Predicate SIDEKICK Rail Fixator K080071 Devices Apex Kirschner Wires and Steinmann Pins K121004 ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite K150661… | 2012 |
| * | K150661 | ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteSummary page 5…irschner Wires and Steinmann Pins K121004 ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite K150661 Device The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides a Description stable solution fo… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252106 | External Fixation Mini Rail System | 2025 | 0 |
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 21 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 46 ancestors have a recall of any class.
- Of its descendants, K252106 (Paragon 28, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080071.
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. 2017, 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 Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162032: Arrowhead Mini-Rail Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162032
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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