510(k) · Cleared
ClearedTrochanteric Dyax Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 14, 2001 after a 22-day review. The FDA summary names its predicate without a number. 132 later devices descend from it.
- Decided
- Nov 14, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
132 later devices descend from it, 3 citing it directly.
- This deviceK013524 Trochanteric Dyax Nail SystemHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 121 of its ownK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 69 of its ownK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
- Descendant · 3 generations on · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 132 · See all- K040212Trigen IntertanSmith & Nephew, Inc. · 2004 · cites it directly121descendants
- K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · 2 generations on69descendants
- K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · 3 generations on60descendants
- K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · 2 generations on35descendants
- K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013524 | Trochanteric Dyax Nail System | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| +2 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| +3 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| +2 | K080434 | Intertan CHS Locking Plate System Prox Fem Plates/Screw | Smith & Nephew, Inc. | 2008 | — |
| +3 | K090656 | Intertan CHS Limited Collapse Set Screw | Smith & Nephew, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 16 | 0 |
| 2025 | 16 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | — | Trochanteric Gamma® Nail System Named without a submission number |
What descends from it? (132)
See all 1323 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, K040212 (Smith & Nephew, Inc., 2004) has gone furthest, with 121 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.
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 device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.
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/K013524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013524: Trochanteric Dyax Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013524
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026