510(k) · Cleared

Cleared

Double Engine Intrameddullary Nail System

K131609510(k) TraditionalCleared May 21, 2014352-day reviewClass II21 CFR 888.3020

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

Xiamen Double Engine Medical Material Co., Ltd. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 21, 2014 as substantially equivalent to K040762 (Synthes (Usa), 2004) after a 352-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: May 21, 2014
Review: 352 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040762 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK040762 Synthes (Usa) Tibial Nail System EXSynthes (Usa) · 2004 · Recalled
This deviceK131609 Double Engine Intrameddullary Nail SystemXiamen Double Engine Medical Material Co., Ltd. · 2014
Descendant · cites it directly · 0 of its ownK253046 HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd. · 2026

Most influential descendants

Showing 1 of 1 · See all

K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040762	Synthes (Usa) Tibial Nail System EX	Synthes (Usa)	2004	2
0 (this device)	K131609	Double Engine Intrameddullary Nail System	Xiamen Double Engine Medical Material Co., Ltd.	2014	—
+1	K253046	HERA Interlocking Intramedullary Nailing System	ZheJiang Decans Medical Devices Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K131609, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K040762	Synthes (Usa) Tibial Nail System EX Summary page 2 …enting rotation. End caps on intramedullarv nails are intended to facilitate removal and to allow length adjustment of the nail. 3.5 Predicate Device Information K040762 Synthes (USA) Tibia] Nail System EX 3.6 Non-Clinical Tests Conclusion Bench tests were conducted to verify that th…	Synthes (Usa)	2004	2

Also cleared against K040762: 10 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K253046	HERA Interlocking Intramedullary Nailing System	ZheJiang Decans Medical Devices Co., Ltd.	2026	0

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?

Its one ancestor has a recall.
Of its descendants, K253046 (ZheJiang Decans Medical Devices Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
10 other devices also cite its predicate K040762.

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. 2014, this device’s year, is highlighted.

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?

Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131609 · printed Nov 5, 2026

Cite this page

510(k) Report. “K131609: Double Engine Intrameddullary Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131609

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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