510(k) · Cleared
ClearedTrauson Intramedullary Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trauson (Jiangsu) Medical Instrument Co., Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jan 13, 2009 as substantially equivalent to K072161 (Biomet Manufacturing Corp, 2007) and 1 other predicate after a 258-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jan 13, 2009
- Review
- 258 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K982953 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 1 generation backK072161 Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp · 2007 · Recalled
- This deviceK081230 Trauson Intramedullary NailTrauson (Jiangsu) Medical Instrument Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −1 | K072161 | Biomet Femoral Locking Nail System | Biomet Manufacturing Corp | 2007 | 8 |
| 0 (this device) | K081230 | Trauson Intramedullary Nail | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072161 | Biomet Femoral Locking Nail SystemSummary page 2…264468 x 809 Email: Diana.hong~mid-link.net Premarket Notification 510(k) Submission-5 10(k) Summary Report No.: 20061014 3.Pr edicate Device K072161 Biomet Femoral Locking Nail System K050241 AOS Humeral Nail 4.De vice Description The Trauson Intramedullary Nail made o… | 2007 |
| * | K050241 | Aos Humeral NailSummary page 2…net Premarket Notification 510(k) Submission-5 10(k) Summary Report No.: 20061014 3.Pr edicate Device K072161 Biomet Femoral Locking Nail System K050241 AOS Humeral Nail 4.De vice Description The Trauson Intramedullary Nail made of medic 11 grade 3 16L stainless steel that… | 2005 |
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 11 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 4 other devices also cite its predicate K072161.
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?
Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081230: Trauson Intramedullary Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081230
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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