510(k) · Cleared

Cleared

Double Medical Femoral Nail System

K172830510(k) TraditionalCleared Aug 24, 2018340-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

Double Medical Technology, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Aug 24, 2018 as substantially equivalent to K070761 (Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod., 2008) and 2 other predicates after a 340-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.

Decided: Aug 24, 2018
Review: 340 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K951740 (1995). 20 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
2 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
1 generation backK070761 Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · 2008
This deviceK172830 Double Medical Femoral Nail SystemDouble Medical Technology, Inc. · 2018
Descendant · cites it directly · 0 of its ownK253080 AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail…Suzhou and Science & Technology Development Corp. · 2026
Descendant · cites it directly · 0 of its ownK253046 HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd. · 2026

Most influential descendants

Showing 2 of 2 · See all

K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026 · cites it directly0descendants
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
−4	K951740	Intramedulary Fixation Rod	Acu Med, Inc.	1995	1
−3	K032722	Trigen Straight Humeral Nail System	Smith & Nephew, Inc.	2003	—
−2	K051557	Trigen Retrograde Femoral, Supracondylar and Tibial Nails	Smith & Nephew, Inc.	2005	—
−1	K070761	Sanatmetal Nails and Pins	Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.	2008	—
0 (this device)	K172830	Double Medical Femoral Nail System	Double Medical Technology, Inc.	2018	—
+1	K253080	AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System…	Suzhou and Science & Technology Development Corp.	2026	—
+1	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	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	2	0

FIG. 1 — Lineage of K172830, 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? (3)

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
*	K070761	Sanatmetal Nails and Pins Summary page 4 …ic bone fixation fastener Regulation Number: 21 CFR 888.3020, 888.3040 Regulatory Classification: Class II Product Code: HSB, HWC 3.3 Predicate Device K070761 Sanatmetal Intramedullary Nails and Pins K043431 Stryker Gamma3® Nail System K040336 Synthes (USA) La…	Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.	2008	—
*	K043431	GAMMA3 Nail System Summary page 4 …3020, 888.3040 Regulatory Classification: Class II Product Code: HSB, HWC 3.3 Predicate Device K070761 Sanatmetal Intramedullary Nails and Pins K043431 Stryker Gamma3® Nail System K040336 Synthes (USA) Lateral Entry Femoral Nail System 3.4 Device Description…	Howmedica Osteonics Corp.	2005	—
*	K040336	Synthes (Usa) Lateral Entry Femoral Nail System Summary page 4 …lass II Product Code: HSB, HWC 3.3 Predicate Device K070761 Sanatmetal Intramedullary Nails and Pins K043431 Stryker Gamma3® Nail System K040336 Synthes (USA) Lateral Entry Femoral Nail System 3.4 Device Description Double Medical Femoral Nail System consists of…	Synthes (Usa)	2004	2

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K253080	AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)	Suzhou and Science & Technology Development Corp.	2026	0
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?

The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
9 of the 20 ancestors have a recall of any class.
Of its descendants, K253080 (Suzhou and Science & Technology Development Corp., 2026) has gone furthest, with 0 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. 2018, 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 Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing. Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include: – Pertrochanteric fractures (31-A1 and 31-A2); – Intertrochanteric fractures (31-A3); – High subtrochanteric fractures (32-A1). Indications for use of the Proximal Femoral Nail…

Read the full statement (158 words)

Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.

Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:

– Pertrochanteric fractures (31-A1 and 31-A2);

– Intertrochanteric fractures (31-A3);

– High subtrochanteric fractures (32-A1).

Indications for use of the Proximal Femoral Nail, Anti-rotation, long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include:

– Low and extended subtrochanteric fractures;

– Ipsilateral trochanteric fractures;

– Combination fractures (in the proximal femur);

– Pathological fractures.

Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include:

– Femoral shaft fractures.

Indications for use of the Universal Femoral Nail II, Cannulated (UFN II) include:

– Standard Locking UFN II: femoral shaft fractures;

– Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures, subtrochanteric fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172830 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172830: Double Medical Femoral 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/K172830

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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