510(k) · Cleared
Recalled · Class II · 2017Trochanteric Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Sep 8, 2004 as substantially equivalent to K010780 (DePuy Orthopaedics, Inc., 2001) and 1 other predicate after a 12-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it. It has been recalled 11 times.
- Decided
- Sep 8, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970097 (1997). 6 ancestors in all, the oldest K871539 (1987). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 2 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 1 generation backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- This deviceK042325 Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK100238 HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125…DePuy Orthopaedics, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · 2 generations on · 2 of its ownK183162 Affixus Hip Fracture NailBiomet, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K100238HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMDePuy Orthopaedics, Inc. · 2010 · cites it directly7descendants
- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · 2 generations on2descendants
- K183162Affixus Hip Fracture NailBiomet, Inc. · 2018 · 2 generations on2descendants
- K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
- K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −2 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −1 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| 0 (this device) | K042325 | Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2004 | — |
| +1 | K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM | DePuy Orthopaedics, Inc. | 2010 | 250 |
| +2 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +2 | K183162 | Affixus Hip Fracture Nail | Biomet, Inc. | 2018 | — |
| +1 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
| +2 | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K010780 | Trochanteric Nail | 2001 |
| * | K013563 | Long Trochanteric Nail SystemSummary page 1…intramedullary nails SUBSTANTIALLY EQUIVALENT DePuy Trochanteric Nail (KO 10780) DEVICES: DePuy Trochanteric Nail (KO013563) DEVICE DESCRIPTION: The Trochanteric Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-ro… | 2001 |
What descends from it? (10)
2 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 |
|---|---|---|---|---|
| Dec 20, 2017 | Class II | Z-1233-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1226-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1227-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1231-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1234-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1229-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1225-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1228-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1230-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1232-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
| Dec 20, 2017 | Class II | Z-1235-2018 | Device Design | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K100238 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K010780.
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 Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042325: Trochanteric 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/K042325
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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