510(k) · Cleared
ClearedSynthes Synsonic Ulna Nail
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 Mar 31, 2014 as substantially equivalent to K042135 (Synthes (Usa), 2004) and 2 other predicates after a 276-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Mar 31, 2014
- Review
- 276 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K042135 (2004). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK042135 Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line…Synthes (Usa) · 2004
- This deviceK131984 Synthes Synsonic Ulna NailSynthes (Usa) · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042135 | Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension) | Synthes (Usa) | 2004 | — |
| 0 (this device) | K131984 | Synthes Synsonic Ulna Nail | Synthes (Usa) | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K042135 | Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)Summary page 1…me: Classification: Classification: 888.3020 Product Code: HSB Predicate Synthes Titanium Elastic Intramedullary Nail System (K042 135) Device: Synthes Olecranon Osteotomy Nail System (K073402) Bonuttti Research, Inc. Unity Ultr… | 2004 |
| * | K073402 | Synthes Olecranon Osteotomy Nailing SystemSummary page 1…Product Code: HSB Predicate Synthes Titanium Elastic Intramedullary Nail System (K042 135) Device: Synthes Olecranon Osteotomy Nail System (K073402) Bonuttti Research, Inc. Unity Ultrasonic System (K0901 75) Device The Synthes Synsonic Uln… | 2008 |
| * | K090175 | Unity Beta Plla SystemSummary page 1…ary Nail System (K042 135) Device: Synthes Olecranon Osteotomy Nail System (K073402) Bonuttti Research, Inc. Unity Ultrasonic System (K0901 75) Device The Synthes Synsonic Ulna Nail System consists of intramedullary nails with Description: end caps… | 2009 |
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?
- None of the 3 ancestors has a recall.
- 8 other devices also cite its predicate K042135.
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. 2014, 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 Synthes Synsonic Ulna Nail System is intended to treat shaft fractures of the ulna, impending pathological fractures, malunions, and nonunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131984: Synthes Synsonic Ulna Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131984
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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