510(k) · Cleared
ClearedAos Modular Femoral 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 Sep 24, 2001 as substantially equivalent to K982953 (Biomet, Inc., 1998) and 2 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it.
- Decided
- Sep 24, 2001
- Review
- 73 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K971135 (1997). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971135 Magellan Intramedullary Femoral Nail SystemWrightmedicaltechnologyinc · 1997
- This deviceK012190 Aos Modular Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK123569 Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK132005 Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · 2 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123569Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013 · cites it directly6descendants
- K132005Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013 · cites it directly4descendants
- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · cites it directly2descendants
- K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on2descendants
- K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc. · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971135 | Magellan Intramedullary Femoral Nail System | Wrightmedicaltechnologyinc | 1997 | — |
| 0 (this device) | K012190 | Aos Modular Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2001 | — |
| +1 | K123569 | Antegrade Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +1 | K132005 | Retrograde Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +1 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +2 | K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous Screw | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +2 | K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails… | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K982953 | Titanium Intramedullary Nails-Various StylesSummary page 2…he TTC fusion insert had three cross locking holes. The AOS Femoral Modular Nail was shown to be substantially equivalent to the following devices. Biomet Uniflex Nail K982953 OrthoMatrix Magellan I.M. Intramedullary Nail K971135 DePuy ACE ACE TTC Fusion Nail K003797 ., : é DEPARTMENT OF… | 1998 |
| * | K971135 | Magellan Intramedullary Femoral Nail SystemSummary page 2…he AOS Femoral Modular Nail was shown to be substantially equivalent to the following devices. Biomet Uniflex Nail K982953 OrthoMatrix Magellan I.M. Intramedullary Nail K971135 DePuy ACE ACE TTC Fusion Nail K003797 ., : é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food an… | 1997 |
| * | K003797 | Ace Aim TTC Fusion NailSummary page 2…to be substantially equivalent to the following devices. Biomet Uniflex Nail K982953 OrthoMatrix Magellan I.M. Intramedullary Nail K971135 DePuy ACE ACE TTC Fusion Nail K003797 ., : é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate B… | 2000 |
What descends from it? (10)
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?
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.
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 Modular Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following. Open and closed femoral fractures Pseudoarthrosis and correction osteotomy Pathologic fractures, impending pathologic fractures, and tumor resections Supracondylar fractures, including those with severe comminution and intra articular extension Ipsilateral femur fractures Bone lengthening Fractures proximal to a total knee…
Read the full statement (105 words)
The AOS Modular Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following. Open and closed femoral fractures Pseudoarthrosis and correction osteotomy Pathologic fractures, impending pathologic fractures, and tumor resections Supracondylar fractures, including those with severe comminution and intra articular extension Ipsilateral femur fractures Bone lengthening Fractures proximal to a total knee arthroplasty or prothesis Fractures distal to a hip joint Nonunions and malunions Fractures resulting from osteoporosis The AOS Femoral Modular Nail is also indicated for use in fusion of the knee and in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia.
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/K012190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012190: Aos Modular Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012190
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026