510(k) · Cleared
ClearedSynthes Angular Stable Locking System (Asls)
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 Jun 17, 2009 after a 135-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Jun 17, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK090241 Synthes Angular Stable Locking System (Asls)Synthes (Usa) · 2009
- Descendant · cites it directly · 17 of its ownK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · Recalled
- 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
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090241 | Synthes Angular Stable Locking System (Asls) | Synthes (Usa) | 2009 | — |
| +1 | K103002 | Synthes Multiloc Proximal Humeral Nailing System | Synthes (Usa) | 2011 | 2 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 | Decided |
|---|---|---|---|
| * | — | Synthes 3.9 mm Ti Locking Bolts Named without a submission number | |
| * | — | Synthes 4.9 mm Ti Locking Bolts Named without a submission number | |
| * | — | Synthes 6.0 mm Locking Screws Named without a submission number |
What descends from it? (18)
See all 182 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103002 (Synthes (Usa), 2011) has gone furthest, with 17 descendants of its own.
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. 2009, 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?
The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090241: Synthes Angular Stable Locking System (Asls).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090241
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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