510(k) · Cleared
ClearedAos Proximal Humeral Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Orthopaedic Solutions, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 26, 2009 as substantially equivalent to K050241 (Advanced Orthopaedic Solutions, Inc., 2005) after a 30-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.
- Decided
- Mar 26, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050241 (2005). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050241 Aos Humeral NailAdvanced Orthopaedic Solutions, Inc. · 2005
- This deviceK090478 Aos Proximal Humeral NailAdvanced Orthopaedic Solutions, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252016 Arthrex Humeral NailsArthrex, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK243890 Arthrex Intramedullary NailsArthrex, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc. · 2013 · cites it directly2descendants
- K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · 2 generations on1descendant
- K252016Arthrex Humeral NailsArthrex, Inc. · 2026 · cites it directly0descendants
- K243890Arthrex Intramedullary NailsArthrex, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050241 | Aos Humeral Nail | Advanced Orthopaedic Solutions, Inc. | 2005 | — |
| 0 (this device) | K090478 | Aos Proximal Humeral Nail | Advanced Orthopaedic Solutions, Inc. | 2009 | — |
| +1 | K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails… | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +2 | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
| +1 | K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026 | — |
| +3 | K243890 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K050241 | Aos Humeral NailSummary page 1…N: 888.3020 Intramedullary Fixation Rod DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICE: AOS Humeral Nail (K050241, Cleared March 14, 2005) INTENDED USE: The AOS Proximal Humeral Nail is intended to treat stable and unstable proximal fractur… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090478: Aos Proximal Humeral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090478
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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