510(k) · Cleared
ClearedAos 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 May 6, 2008 as substantially equivalent to K011815 (Synthes (Usa), 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- May 6, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011815 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011815 Synthes LCP Proximal Humerus PlatesSynthes (Usa) · 2001
- This deviceK080590 Aos Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK160409 AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK171606 AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
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 | K011815 | Synthes LCP Proximal Humerus Plates | Synthes (Usa) | 2001 | — |
| 0 (this device) | K080590 | Aos Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2008 | — |
| +1 | K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2016 | — |
| +2 | K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 1…accessories. DEVICE CODE: KTW SUBSTANTIALLY EQUIVALENT DEVICE: Synthes LCP Proximal Humeral Plate (K01 1815 and K04186) DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES: The AOS Proximal H… | 2001 |
| Kept off the family tree | K041806 | FDA’s K041806 is Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| † | K050241 | Aos Humeral Nail | 2005 |
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 |
|---|---|---|---|
| K160409 | AOS Anterolateral Proximal Humeral Plate | 2016 | 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 KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080590: Aos 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/K080590
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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