510(k) · Cleared

Cleared

HERA Interlocking Intramedullary Nailing System

K253046510(k) TraditionalCleared Jun 16, 2026267-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

ZheJiang Decans Medical Devices Co., Ltd. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jun 16, 2026 as substantially equivalent to K172830 (Double Medical Technology, Inc., 2018) and 3 other predicates after a 267-day review. Its family tree reaches back 5 generations to 1995.

Decided: Jun 16, 2026
Review: 267 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K951740 (1995). 24 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
4 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
3 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
2 generations backK070761 Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · 2008
1 generation backK172830 Double Medical Femoral Nail SystemDouble Medical Technology, Inc. · 2018
This deviceK253046 HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K951740	Intramedulary Fixation Rod	Acu Med, Inc.	1995	1
−4	K032722	Trigen Straight Humeral Nail System	Smith & Nephew, Inc.	2003	—
−3	K051557	Trigen Retrograde Femoral, Supracondylar and Tibial Nails	Smith & Nephew, Inc.	2005	—
−2	K070761	Sanatmetal Nails and Pins	Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.	2008	—
−1	K172830	Double Medical Femoral Nail System	Double Medical Technology, Inc.	2018	—
0 (this device)	K253046	HERA Interlocking Intramedullary Nailing System	ZheJiang Decans Medical Devices Co., Ltd.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	4	0
1999	2	0
2000	1	0
2001	3	0
2002	1	0
2003	1	0
2004	5	0
2005	1	0
2014	1	0

FIG. 1 — Lineage of K253046, 1995–2026Source: 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? (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	Applicant	Decided	Recalls
*	K172830	Double Medical Femoral Nail System Summary page 5 …Double Medical Technology Inc. Trade name Double Medical Femoral Nail System 510(k) K172830 Primary Predicate Regulatory Class II Device Regulation Number 21CFR 888.3020, 21CFR888.3040…	Double Medical Technology, Inc.	2018	—
*	K040212	Trigen Intertan Summary page 5 …Manufacturer Smith & Nephew, Inc. Trade name TriGen InterTAN 510(k) K040212 Additional Predicate Regulatory Class II Device Regulation Number 21CFR 888.3030…	Smith & Nephew, Inc.	2004	6
*	K040462	Trigen Trochanteric Antegrade Nail Summary page 5 …cturer Smith & Nephew, Inc. Trade name TriGen Trochanteric Antegrade Nail 510(k) K040462 Additional Predicate Regulatory Class II Device Regulation Number 21…	Smith & Nephew, Inc.	2004	2
*	K131609	Double Engine Intrameddullary Nail System Summary page 6 …K253046 - Page 2 of 3 510(k) K131609 Regulatory Class II Regulation Number 21CFR 888.3020…	Xiamen Double Engine Medical Material Co., Ltd.	2014	—

Also cleared against K172830: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
11 of the 24 ancestors have a recall of any class.
1 other device also cites its predicate K172830.

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. 2026, 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?

(1)Femoral Trochanteric Fixation Nail System Femoral Trochanteric Fixation Nail System is intended use to: a)Pertrochanteric, intertrochanteric or Subtrochanteric fractures; b)Combination fractures of femur; c)Pathological fractures or reconstruction following tumor resection and grafting; d)Poor healing of fracture, including nonunions, malunions and bone lengthening or shortening; e)Other fracture, including simple severely comminuted, spiral, long…

Read the full statement (117 words)

(1)Femoral Trochanteric Fixation Nail System

Femoral Trochanteric Fixation Nail System is intended use to:

a)Pertrochanteric, intertrochanteric or Subtrochanteric fractures;

b)Combination fractures of femur;

c)Pathological fractures or reconstruction following tumor resection and grafting;

d)Poor healing of fracture, including nonunions, malunions and bone lengthening or shortening;

e)Other fracture, including simple severely comminuted, spiral, long oblique and segmental fractures of femur.

(2)Antegrade Femoral Reconstruction Nail System

Antegrade Femoral Reconstruction Nail System rencon mode is intended use to Femoral shaft and neck fracture ; standard mode is intended use to Femoral shaft fracture.

(3)Tibial Nail system

Tibial 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K253046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K253046: HERA Interlocking Intramedullary Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253046

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026