510(k) · Cleared
ClearedAOS Small Bone Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Orthopaedic Solutions, Inc. (Aos) · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jan 24, 2017 as substantially equivalent to K971783 (Synthes (Usa), 1997) and 3 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jan 24, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K960642 (1996). 13 ancestors in all, the oldest K913949 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 2 generations backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
- 1 generation backK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
- This deviceK163014 AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
- Descendant · cites it directly · 0 of its ownK234128 Phantom Fibula Nail SystemParagon 28, Inc. · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K234128Phantom Fibula Nail SystemParagon 28, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −4 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −3 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −2 | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (Usa) | 2008 | — |
| −1 | K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 | — |
| 0 (this device) | K163014 | AOS Small Bone Nailing System | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017 | — |
| +1 | K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 4…n Rod/Pin DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICES: Synthes Elastic Intramedullary Nail (EIN) K971783 Acumed Small Bone Locking Rod System II K031438 Acumed Small… | 1997 |
| * | K031438 | Acumed Small Bone Locking Rod System IISummary page 4…IALLY EQUIVALENT DEVICES: Synthes Elastic Intramedullary Nail (EIN) K971783 Acumed Small Bone Locking Rod System II K031438 Acumed Small Bone IM Nail System K143276 Smith & Neph… | 2003 |
| * | K143276 | Acumed Small Bone IM Nail SystemSummary page 4…71783 Acumed Small Bone Locking Rod System II K031438 Acumed Small Bone IM Nail System K143276 Smith & Nephew Intramedullary Nail System K983942 DEVICE DESCRIPTION: The AOS Sm… | 2015 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 4…31438 Acumed Small Bone IM Nail System K143276 Smith & Nephew Intramedullary Nail System K983942 DEVICE DESCRIPTION: The AOS Small Bone Nail is a titanium alloy (Ti-6Al- 4V) intramed… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234128 | Phantom Fibula Nail System | 2024 | 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 21 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K234128 (Paragon 28, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K971783.
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. 2017, 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 Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna,
including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163014 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163014: AOS Small Bone 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/K163014
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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