510(k) · Cleared
ClearedAOS Clavicle Intramedullary Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Orthopaedic Solutions, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 3, 2015 as substantially equivalent to K103001 (DePuy Orthopaedics, Inc., 2011) after a 208-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 3, 2015
- Review
- 208 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903258 (1990). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK903258 Hagie PinOnyx Medical Corp. · 1990
- 2 generations backK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
- 1 generation backK103001 Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
- This deviceK143204 AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK163488 Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903258 | Hagie Pin | Onyx Medical Corp. | 1990 | — |
| −2 | K991649 | Depuy Rockwood Clavicle Pin | Depuy, Inc. | 1999 | — |
| −1 | K103001 | Rockwood Clavicle Pins | DePuy Orthopaedics, Inc. | 2011 | — |
| 0 (this device) | K143204 | AOS Clavicle Intramedullary Device | Advanced Orthopaedic Solutions, Inc. | 2015 | — |
| +1 | K163488 | Flex-Thread Clavicle Pin System | Intrafuse, LLC | 2017 | — |
| +2 | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K103001 | Rockwood Clavicle PinsSummary page 4…HSB and JDW SUBSTANTIALLY EQUIVALENT DEVICES: Primary Predicate: DePuy Orthopaedics Rockwood Clavicle Pin (510(k): K103001, Cleared February 17, 2011); Reference Device: Sonoma Orthopedic En… | 2011 |
| † | K081832 | Ensplintcmx Clavicle Pin | 2008 |
| † | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163488 | Flex-Thread Clavicle Pin System | 2017 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K163488 (Intrafuse, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K103001.
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. 2015, 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 AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or non-union of the Clavicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143204 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143204: AOS Clavicle Intramedullary Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143204
Report an extraction error
Are you the manufacturer?
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