510(k) · Cleared
Recalled · Class II · 2017Long Trochanteric 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 Dec 27, 2001 as substantially equivalent to K010780 (DePuy Orthopaedics, Inc., 2001) and 3 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1997. 70 later devices descend from it. It has been recalled 54 times.
- Decided
- Dec 27, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 54
- Predicates
- 4
Its longest line of descent runs back 2 generations to K970097 (1997). 5 ancestors in all, the oldest K871539 (1987). 70 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 1 generation backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- This deviceK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 53 of its ownK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- Descendant · 2 generations on · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 29 of its ownK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · 4 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
2002high 8 (2025) · low 0 (2005)2026
Most influential descendants
Showing 5 of 70 · See all- K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003 · cites it directly53descendants
- K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · 2 generations on39descendants
- K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · 2 generations on29descendants
- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 3 generations on17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −1 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| 0 (this device) | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | — |
| +1 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| +2 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| +2 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| +3 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +4 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (4)
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 NailSummary page 1…E or 87HSB No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails. ACE Trochanteric Nail K010780 ACE AIM Femoral Nail K871539 Synthes Proximal Femoral Nail K973240 Smith & Nephew TriGen Nail =~ K981529 The Trochanteric Long N… | 2001 |
| * | K871539 | Zindrick IM RodSummary page 1…andards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails. ACE Trochanteric Nail K010780 ACE AIM Femoral Nail K871539 Synthes Proximal Femoral Nail K973240 Smith & Nephew TriGen Nail =~ K981529 The Trochanteric Long Nail System consists of an int… | 1987 |
| * | K973240 | Synthes Proximal Femoral Nail (PFN) System ModificationSummary page 1…ction 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails. ACE Trochanteric Nail K010780 ACE AIM Femoral Nail K871539 Synthes Proximal Femoral Nail K973240 Smith & Nephew TriGen Nail =~ K981529 The Trochanteric Long Nail System consists of an intramedullary nail, lag screw, end cap,… | 1997 |
| * | K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewSummary page 1…nd Cosmetic Act for intramedullary nails. ACE Trochanteric Nail K010780 ACE AIM Femoral Nail K871539 Synthes Proximal Femoral Nail K973240 Smith & Nephew TriGen Nail =~ K981529 The Trochanteric Long Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all… | 1998 |
What descends from it? (70)
See all 703 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-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-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-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-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… |
| 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-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-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-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-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-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-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 11, 2003 | Not classified | Z-0395-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0414-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0404-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0409-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0408-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0398-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0455-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0451-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0401-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0460-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0406-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0394-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0399-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0419-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0416-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0413-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0456-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0415-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0407-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0405-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0462-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0410-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0397-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0461-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0400-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0458-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0411-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0417-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0391-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0418-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0450-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0402-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0454-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0452-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0453-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0392-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0457-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0459-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Dec 11, 2003 | Not classified | Z-0390-04 | Other | The lag screw may migrate to the femoral head or into the abdominal cavity. |
The 5 latest of 50 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 4 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K033329 (Depuy, Inc., 2003) has gone furthest, with 53 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
2007high 23 (2017) · low 8 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
2007high 195 (2024) · low 57 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
2007high 81 (2009) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
2007high 4,111 (2021) · low 162 (2007)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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013563: Long Trochanteric Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013563
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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