510(k) · Cleared

Cleared

Synthes Multiloc Humeral Nailing System

K120807510(k) TraditionalCleared Jul 6, 2012112-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

Synthes USA Products, LLC · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jul 6, 2012 as substantially equivalent to K033071 (Synthes (Usa), 2003) and 4 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1995. 15 later devices descend from it.

Decided: Jul 6, 2012
Review: 112 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K951740 (1995). 14 ancestors in all. 15 later devices descend from it, 3 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 backK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
1 generation backK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · Recalled
This deviceK120807 Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012
Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Descendant · 2 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
Descendant · cites it directly · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
Descendant · 3 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
Descendant · 2 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2014high 3 (2017) · low 0 (2015)2026

Most influential descendants

Showing 5 of 15 · See all

K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 2 generations on3descendants
K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · cites it directly2descendants
K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 3 generations on2descendants
K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on2descendants

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	K082754	Aequalis Humeral Nail System	Tornier	2009	2
−1	K103002	Synthes Multiloc Proximal Humeral Nailing System	Synthes (Usa)	2011	2
0 (this device)	K120807	Synthes Multiloc Humeral Nailing System	Synthes USA Products, LLC	2012	—
+1	K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…	I.T.S. GmbH	2014	—
+2	K161327	Syntec Humeral Nail System	Syntec Scientific Corporation	2017	—
+1	K192003	Auxein Nailing System	Auxein Medical Private Limited	2020	—
+3	K181296	Syntec Femoral Nail System	Syntec Scientific Corporation	2019	—
+2	K141228	Aos 6.5MM Captured, Fully Threaded Cancellous Screw	Advanced Orthopaedic Solutions, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2000	2	0
2003	2	0
2004	3	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2017	3	0
2019	2	0
2020	2	0
2021	1	0
2023	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K120807, 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? (5)

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
*	K033071	Synthes (Usa) Cannulated Titanium Humeral Nail System Summary page 1 …lass 11, §888.3020 - Intraimedullary fixation rod Product Code: HSB Predicate Device: Synthes Cannulated Titanium Humneral Nail System (K033071) Synthes MultiLoc Proximal Humeral Nailing System (K]103002) Synthes Angular…	Synthes (Usa)	2003	2
*	K103002	Synthes Multiloc Proximal Humeral Nailing System Summary page 1 …e: HSB Predicate Device: Synthes Cannulated Titanium Humneral Nail System (K033071) Synthes MultiLoc Proximal Humeral Nailing System (K]103002) Synthes Angular Stable Locking System [ASLS] (K090241) Synthes 4.0mm and…	Synthes (Usa)	2011	2
*	K090241	Synthes Angular Stable Locking System (Asls) Summary page 1 …033071) Synthes MultiLoc Proximal Humeral Nailing System (K]103002) Synthes Angular Stable Locking System [ASLS] (K090241) Synthes 4.0mm and 5.0mm Locking Screws (K000089) Synthes 3.5mm Loc…	Synthes (Usa)	2009	—
*	K000089	Synthes 4.0 and 5.0 MM Locking Screws Summary page 1 …]103002) Synthes Angular Stable Locking System [ASLS] (K090241) Synthes 4.0mm and 5.0mm Locking Screws (K000089) Synthes 3.5mm Locking Screws (K000684) Device Description: The Synthes Multi…	Synthes (Usa)	2000	—
*	K000684	Small Fragment Dynamic Compression Locking (DCL) System Summary page 1 …K090241) Synthes 4.0mm and 5.0mm Locking Screws (K000089) Synthes 3.5mm Locking Screws (K000684) Device Description: The Synthes MultiLoc Humeral Nailing System consists of metallic rods and ac…	Synthes (Usa)	2000	1

Also cleared against K033071: 5 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail	I.T.S. GmbH	2014	10
K192003	Auxein Nailing System	Auxein Medical Private Limited	2020	2
K160553	DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2017	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 17 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
7 of the 14 ancestors have a recall of any class.
Of its descendants, K132945 (I.T.S. GmbH, 2014) has gone furthest, with 10 descendants of its own.
5 other devices also cite its predicate K033071.

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. 2012, 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?

The Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120807 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120807: Synthes Multiloc Humeral 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/K120807

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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