510(k) · Cleared
Recalled · Class II · 2024Synthes Trochanteric Fixation Nail - Advanced System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 28, 2014 after a 274-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 9 times.
- Decided
- Feb 28, 2014
- Review
- 274 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 9
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK131548 Synthes Trochanteric Fixation Nail - Advanced SystemSynthes (USA) Products, LLC · 2014
- Descendant · cites it directly · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · cites it directly · 2 of its ownK182783 DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
- Descendant · cites it directly · 2 of its ownK171108 AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK220659 AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · cites it directly2descendants
- K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018 · cites it directly2descendants
- K171108AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017 · cites it directly2descendants
- K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022 · 2 generations on1descendant
- K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131548 | Synthes Trochanteric Fixation Nail - Advanced System | Synthes (USA) Products, LLC | 2014 | — |
| +1 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +1 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 | — |
| +1 | K171108 | AUTOBAHN Nailing System | Globus Medical, Inc. | 2017 | — |
| +2 | K220659 | AUTOBAHN (R) EVO Femoral Nails | Globus Medical, Inc. | 2022 | — |
| +2 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2024 | Class II | Z-1239-2024 | Process control | Products not sterilized, sterility cannot be confirmed |
| Jan 24, 2024 | Class II | Z-1240-2024 | Process control | Products not sterilized, sterility cannot be confirmed |
| Feb 1, 2023 | Class II | Z-1246-2023 | Under Investigation by firm | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| Feb 1, 2023 | Class II | Z-1248-2023 | Under Investigation by firm | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| Feb 1, 2023 | Class II | Z-1247-2023 | Under Investigation by firm | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| Sep 21, 2015 | Class II | Z-0126-2016 | Device Design | Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument. |
| Jun 10, 2015 | Class II | Z-2091-2015 | Process control | The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017). |
| Apr 9, 2015 | Class II | Z-1600-2015 | Process control | TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay. |
| Feb 24, 2015 | Class II | Z-1352-2015 | Component design/selection | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192003 (Auxein Medical Private Limited, 2020) 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. 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 | — |
https://510kreport.com/device/K131548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131548: Synthes Trochanteric Fixation Nail - Advanced System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131548
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026