510(k) · Cleared
ClearedSynthes Olecranon Osteotomy Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 29, 2008 after an 87-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 29, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK073402 Synthes Olecranon Osteotomy Nailing SystemSynthes (Usa) · 2008
- Descendant · cites it directly · 2 of its ownK182783 DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
- Descendant · cites it directly · 2 of its ownK081356 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK090091 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018 · cites it directly2descendants
- K081356Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2008 · cites it directly2descendants
- K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2009 · 2 generations on1descendant
- K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
- K201830ANSER Clavicle PinBAAT Medical Products B.V. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073402 | Synthes Olecranon Osteotomy Nailing System | Synthes (Usa) | 2008 | — |
| +1 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 | — |
| +1 | K081356 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2008 | — |
| +2 | K090091 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2009 | — |
| +2 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
| +2 | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (5)
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 |
|---|---|---|---|
| * | — | Pioneer Surgical Technology SS Cables with Crimp Named without a submission number | |
| * | — | Synthes Kirschner Wires Named without a submission number | |
| * | — | Synthes 6.5mm Cancellous Screws Named without a submission number | |
| * | — | Acumed Small Bone Locking Rod System Named without a submission number | |
| * | — | Biomet S.S.T- Small Bone Locking Forearm Nail Named without a submission number |
What descends from it? (8)
4 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?
- Of its descendants, K182783 (DePuy Synthes, 2018) has gone furthest, with 2 descendants of its own.
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. 2008, 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?
Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073402: Synthes Olecranon Osteotomy Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073402
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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