510(k) · Cleared
ClearedAos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Orthopaedic Solutions, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 29, 2014 as substantially equivalent to K080408 (Advanced Orthopaedic Solutions, Inc., 2008) and 4 other predicates after a 106-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Oct 29, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K961916 (1996). 22 ancestors in all, the oldest K861766 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961916 Hoffmann II Carbon Connecting RodHowmedica, Inc. · 1996
- 1 generation backK080408 External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100…Advanced Orthopaedic Solutions, Inc. · 2008
- This deviceK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961916 | Hoffmann II Carbon Connecting Rod | Howmedica, Inc. | 1996 | — |
| −1 | K080408 | External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External… | Advanced Orthopaedic Solutions, Inc. | 2008 | — |
| 0 (this device) | K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External… | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +1 | K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K080408 | External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp…Summary page 4…Metallic Bone Fixation Appliance and Accessories DEVICE CODE: KTT; JDW SUBSTANTIALLY EQUIVALENT DEVICES: AOS External Fixation System (510(k): K080408, Cleared April 25, 2008); Stryker Hoffmann II Compact External Fixation Sys… | 2008 |
| * | K971755 | Hoffmann II Compact External Fixation SystemSummary page 4…April 25, 2008); Stryker Hoffmann II Compact External Fixation System and Hoffmann Fixation Pin System (510(k): K971755/K861766, Cleared July 17, 1997 and July 08, 1986); Hoffmann Il Micro External Fixation… | 1997 |
| * | K861766 | Howmedica Hoffmann Fixation Pin SystemSummary page 4…l 25, 2008); Stryker Hoffmann II Compact External Fixation System and Hoffmann Fixation Pin System (510(k): K971755/K861766, Cleared July 17, 1997 and July 08, 1986); Hoffmann Il Micro External Fixation… | 1986 |
| * | K042019 | Hoffmann II Micro External Fixation SystemSummary page 4…(510(k): K971755/K861766, Cleared July 17, 1997 and July 08, 1986); Hoffmann Il Micro External Fixation System, K042019(Cleared September 24, 2004); DePuy Synthes Small External Fixation System (510(k): K122455,… | 2004 |
| * | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemSummary page 4…xternal Fixation System, K042019(Cleared September 24, 2004); DePuy Synthes Small External Fixation System (510(k): K122455, Cleared April 11, 2013) DEVICE DESCRIPTION: The AOS Small External Fixation System is an exte… | 2013 |
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 |
|---|---|---|---|
| K232897 | Arthrex Small External Fixation System | 2023 | 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 18 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 8 of the 22 ancestors have a recall of any class.
- Of its descendants, K232897 (Arthrex, Inc., 2023) has gone furthest, with 0 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. 2014, 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 AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments.
The AOS Small External Fixation System is intended to be non-weight bearing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141912
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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