510(k) · Cleared
ClearedExternal Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp, 9.5MM Rod
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 Apr 25, 2008 as substantially equivalent to K053472 (Howmedica Osteonics Corp., 2006) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Apr 25, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K961916 (1996). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961916 Hoffmann II Carbon Connecting RodHowmedica, Inc. · 1996
- This deviceK080408 External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100…Advanced Orthopaedic Solutions, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961916 | Hoffmann II Carbon Connecting Rod | Howmedica, Inc. | 1996 | — |
| 0 (this device) | K080408 | External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External… | Advanced Orthopaedic Solutions, Inc. | 2008 | — |
| +1 | K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External… | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +2 | K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K053472 | Hoffmann II Mri External Fixation SystemSummary page 1…accessories. DEVICE CODE: KTT SUBSTANTIALLY EQUIVALENT DEVICE: Hoffman II External Fixation System (K053472) Apex Fixation Pins (K011136) DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:… | 2006 |
| * | K011136 | Apex Fixation PinsSummary page 1…KTT SUBSTANTIALLY EQUIVALENT DEVICE: Hoffman II External Fixation System (K053472) Apex Fixation Pins (K011136) DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES: The AOS External Fixation System is an external fixation device com… | 2001 |
| * | K961916 | Hoffmann II Carbon Connecting RodSummary page 2…ystem is based on the similarity in indication for use, design features, operating principles and material of composition to Stryker's Hoffman II Carbon Connecting Rods, K961916, Stryker's Hoffman II External Fixation System, K053472 and Stryker's Apex Fixation Pins, K01 1136. The construct of the AOS Ext… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation… | 2014 | 1 |
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?
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. 2008, 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 External Fixation System is indicated for external fixation of open or
closed long bone fractures where soft tissue injury precludes the use of other
fracture treatment.
The AOS External Fixation System is intended to be non-weight bearing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080408: External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp, 9.5MM Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080408
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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