510(k) · Cleared
ClearedArthrex Humeral Nails
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 20, 2026 as substantially equivalent to K050241 (Advanced Orthopaedic Solutions, Inc., 2005) and 2 other predicates after a 266-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 20, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951740 (1995). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
- 1 generation backK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · Recalled
- This deviceK252016 Arthrex Humeral NailsArthrex, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −3 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K082754 | Aequalis Humeral Nail System | Tornier | 2009 | 2 |
| −1 | K103002 | Synthes Multiloc Proximal Humeral Nailing System | Synthes (Usa) | 2011 | 2 |
| 0 (this device) | K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 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? (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 |
|---|---|---|---|
| * | K050241 | Aos Humeral NailSummary page 5…t Code HSB Classification Name 21 CFR 888.3020: Intramedullary Fixation Rod Regulatory Class II Primary Predicate Device K050241 AOS Humeral Nail Additional Predicate Devices K090478 AOS Proximal Humeral Nail K103002 Synthes… | 2005 |
| * | K090478 | Aos Proximal Humeral NailSummary page 5…21 CFR 888.3020: Intramedullary Fixation Rod Regulatory Class II Primary Predicate Device K050241 AOS Humeral Nail Additional Predicate Devices K090478 AOS Proximal Humeral Nail K103002 Synthes MultiLoc Humeral Nailing System Reference Predicate… | 2009 |
| * | K103002 | Synthes Multiloc Proximal Humeral Nailing SystemSummary page 5…II Primary Predicate Device K050241 AOS Humeral Nail Additional Predicate Devices K090478 AOS Proximal Humeral Nail K103002 Synthes MultiLoc Humeral Nailing System Reference Predicate K210792 AUXEIIN Humeral Nail System Purpose of Submission… | 2011 |
| † | K210792 | Auxein Nailing System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 8.1 years on median.
- 7 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K050241.
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. 2026, 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 Arthrex Humeral Nail System is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.
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/K252016 · printed Nov 3, 2026
Cite this page
510(k) Report. “K252016: Arthrex Humeral Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K252016
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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