510(k) · Cleared
ClearedAOS Anterolateral Proximal Humeral Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Orthopaedic Solutions, Inc. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Mar 15, 2016 as substantially equivalent to K080590 (Advanced Orthopaedic Solutions, Inc., 2008) after a 28-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Mar 15, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011815 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011815 Synthes LCP Proximal Humerus PlatesSynthes (Usa) · 2001
- 1 generation backK080590 Aos Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2008
- This deviceK160409 AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK171606 AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
Most influential descendants
Showing 1 of 1 · See all- K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011815 | Synthes LCP Proximal Humerus Plates | Synthes (Usa) | 2001 | — |
| −1 | K080590 | Aos Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2008 | — |
| 0 (this device) | K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2016 | — |
| +1 | K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K080590 | Aos Proximal Humeral PlateSummary page 4…ixation appliances and accessories DEVICE CODE: KTW SUBSTANTIALLY EQUIVALENT DEVICE: AOS Proximal Humeral Plate (K080590, May 6, 2008) DEVICE DESCRIPTION: The AOS Anterolateral Proximal Humeral plates are… | 2008 |
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 |
|---|---|---|---|
| K171606 | AOS Anterolateral Proximal Humeral Plate | 2017 | 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 15 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171606 (Advanced Orthopaedic Solutions, Inc. (Aos), 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160409: AOS Anterolateral Proximal Humeral Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160409
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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