510(k) · Cleared
Recalled · Class II · 2012Synthes Multiloc Proximal Humeral Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 2, 2011 as substantially equivalent to K033071 (Synthes (Usa), 2003) and 5 other predicates after a 145-day review. Its family tree reaches back 3 generations to 1995. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 2, 2011
- Review
- 145 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 3 generations to K951740 (1995). 13 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 2 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 1 generation backK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
- This deviceK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011
- Descendant · cites it directly · 15 of its ownK120807 Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012
- Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 3 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · 2 generations on · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · 4 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012 · cites it directly15descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 3 generations on3descendants
- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · 2 generations on2descendants
- K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −2 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −1 | K082754 | Aequalis Humeral Nail System | Tornier | 2009 | 2 |
| 0 (this device) | K103002 | Synthes Multiloc Proximal Humeral Nailing System | Synthes (Usa) | 2011 | — |
| +1 | K120807 | Synthes Multiloc Humeral Nailing System | Synthes USA Products, LLC | 2012 | — |
| +2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +3 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +2 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +4 | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 | 3 | 0 |
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
What was it cleared against? (6)
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 | Decided |
|---|---|---|---|
| * | K033071 | Synthes (Usa) Cannulated Titanium Humeral Nail SystemSummary page 1…Class 11, §888.3020 - Intramedullary fixation rod Product Code: HSB Predicate Device: Synthes Cannulated Titanium Humeral Nail System (K033071I) Tomnier Aequalis Humneral Nail System (K082754) Synthes Ang… | 2003 |
| * | K082754 | Aequalis Humeral Nail SystemSummary page 1…HSB Predicate Device: Synthes Cannulated Titanium Humeral Nail System (K033071I) Tomnier Aequalis Humneral Nail System (K082754) Synthes Angular Stable Locking System [ASLS] (K090241) Synthes 4.0m… | 2009 |
| * | K090241 | Synthes Angular Stable Locking System (Asls)Summary page 1…Tomnier Aequalis Humneral Nail System (K082754) Synthes Angular Stable Locking System [ASLS] (K090241) Synthes 4.0mm and 5.0mm Locking Screws (1(000089) Synthes 3.… | 2009 |
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 1…Synthes Angular Stable Locking System [ASLS] (K090241) Synthes 4.0mm and 5.0mm Locking Screws (1(000089) Synthes 3.5mm LCP Proximal Humerus Plates (K04 1860) Synthes 3.5… | 2000 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 1…Synthes 4.0mm and 5.0mm Locking Screws (1(000089) Synthes 3.5mm LCP Proximal Humerus Plates (K04 1860) Synthes 3.5mm Locking Screws (K000684) Device Description: The Synthes… | 2004 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…Synthes 3.5mm LCP Proximal Humerus Plates (K04 1860) Synthes 3.5mm Locking Screws (K000684) Device Description: The Synthes MultiLoc Proximal Humneral Nailing System consists of metallic rods… | 2000 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2012 | Class II | Z-2059-2012 | Error in labeling | Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. |
| May 22, 2012 | Class II | Z-2060-2012 | Error in labeling | Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K120807 (Synthes USA Products, LLC, 2012) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K033071.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 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?
Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103002 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103002: Synthes Multiloc Proximal Humeral Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103002
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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