510(k) · Cleared

Recalled · Class II · 2017

Trochanteric Nail

K010780510(k) TraditionalCleared Jun 12, 200189-day reviewClass II21 CFR 888.3020Recalls 84

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jun 12, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 168 later devices descend from it. It has been recalled 84 times.

Decided: Jun 12, 2001
Review: 89 days
Class: Class II
Product code: HSB
Recalls: 84
Predicates: 0

168 later devices descend from it, 6 citing it directly.

This deviceK010780 Trochanteric NailDePuy Orthopaedics, Inc. · 2001
Descendant · cites it directly · 121 of its ownK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
Descendant · cites it directly · 70 of its ownK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · 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 · cites it directly · 53 of its ownK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003

Showing 5 of 168 descendants. See all descendants

Descendants cleared per year

2001high 19 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 168 · See all

K040212Trigen IntertanSmith & Nephew, Inc. · 2004 · cites it directly121descendants
K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly70descendants
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
K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003 · cites it directly53descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010780	Trochanteric Nail	DePuy Orthopaedics, Inc.	2001	—
+1	K040212	Trigen Intertan	Smith & Nephew, Inc.	2004	6
+1	K013563	Long Trochanteric Nail System	DePuy Orthopaedics, Inc.	2001	54
+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
+1	K033329	Depuy Ace Universal and Troch Entry Femoral Nail Systems	Depuy, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2004	4	0
2005	2	0
2006	1	0
2007	1	0
2008	2	0
2009	6	0
2010	3	0
2011	6	0
2012	6	0
2013	8	0
2014	7	0
2015	5	0
2016	1	0
2017	6	0
2018	12	0
2019	6	0
2020	10	0
2021	7	0
2022	11	0
2023	11	0
2024	17	0
2025	19	0
2026	14	0

FIG. 1 — Lineage of K010780, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (168)

See all 168

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040212	Trigen Intertan	Smith & Nephew, Inc.	2004	121
K013563	Long Trochanteric Nail System	DePuy Orthopaedics, Inc.	2001	70
K033329	Depuy Ace Universal and Troch Entry Femoral Nail Systems	Depuy, Inc.	2003	53
K021008	Advanced Orthopaedic Solutions Trochanteric Nail	Advanced Orthopaedic Solutions, Inc.	2002	13
K042325	Trochanteric Nail System	DePuy Orthopaedics, Inc.	2004	10
K042440	Alphatec Femoral Trochanteric Nail (FTN) System	Alphatec/Nexmed	2004	0

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-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-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-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-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-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-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-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-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…
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-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 11, 2003	Not classified	Z-0465-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0445-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0467-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0471-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0424-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0421-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0475-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0469-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0428-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0477-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0472-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0464-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0437-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0434-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0481-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0441-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0463-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0446-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0423-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0470-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0420-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0473-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0444-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0468-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0426-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0476-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0430-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0478-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0429-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0480-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0438-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0435-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0482-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0474-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0425-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0483-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0447-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0466-04	Other	The lag screw may migrate to the femoral head or into the abdominal cavity.
Dec 11, 2003	Not classified	Z-0443-04	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?

Of its descendants, K040212 (Smith & Nephew, Inc., 2004) has gone furthest, with 121 descendants of its own.

How does its category compare?

All HSB devices

HSB 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	—

https://510kreport.com/device/K010780 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010780: Trochanteric Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010780

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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