510(k) · Cleared
ClearedAos Tibial Nail
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 14, 2007 as substantially equivalent to K032097 (DePuy Orthopaedics, Inc., 2003) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 14, 2007
- Review
- 119 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951740 (1995). 15 ancestors in all, the oldest K914453 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 1 generation backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK070444 Aos Tibial NailAdvanced Orthopaedic Solutions, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK130625 12MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243890 Arthrex Intramedullary NailsArthrex, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc. · 2013 · cites it directly3descendants
- K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc. · 2013 · cites it directly2descendants
- K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · cites it directly1descendant
- K243890Arthrex Intramedullary NailsArthrex, Inc. · 2025 · 2 generations on0descendants
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 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −1 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K070444 | Aos Tibial Nail | Advanced Orthopaedic Solutions, Inc. | 2007 | — |
| +1 | K130625 | 12MM and 13MM Tibial Nails | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +1 | K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails… | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +1 | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
| +2 | K243890 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K032097 | Depuy Ace Versanail Tibial NailSummary page 1…ry Fixation Rod DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICE: DePuy VersaNail Tibial Nail (K032097) Smith & Nephew TriGen Meta-Nail Tibial Nail System… | 2003 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 1…Tibial Nail (K032097) Smith & Nephew TriGen Meta-Nail Tibial Nail System (K06 1019) Stryker Trauma T2 Tibial Nail System DEVICE DESCRIPTION AND SUBSTANTI… | 2006 |
| * | — | Stryker Trauma T2 Tibial Nail System Named without a submission number |
What descends from it? (4)
3 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K130625 (Advanced Orthopaedic Solutions, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K032097.
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. 2007, 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 Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the tibia.
The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following:
Transverse, oblique, spiral, segmental and comminuted fractures;
Fractures with bone loss and bone transport;
Open and closed fractures, pathologic fractures;
Corrective osteotomies pseudarthrosis of the tibial shaft"
Nonunions, malunions, metaphyseal and epiphyseal fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070444: Aos Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070444
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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