510(k) · Cleared
ClearedRetrograde 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 10, 2013 as substantially equivalent to K012190 (Advanced Orthopaedic Solutions, Inc., 2001) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 10, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971135 (1997). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK971135 Magellan Intramedullary Femoral Nail SystemWrightmedicaltechnologyinc · 1997
- 2 generations backK012190 Aos Modular Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2001
- 1 generation backK123569 Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013
- This deviceK132005 Retrograde Femoral NailAdvanced 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
- Descendant · cites it directly · 0 of its ownK191598 AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- 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
- K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971135 | Magellan Intramedullary Femoral Nail System | Wrightmedicaltechnologyinc | 1997 | — |
| −2 | K012190 | Aos Modular Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2001 | — |
| −1 | K123569 | Antegrade Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| 0 (this device) | K132005 | Retrograde Femoral Nail | 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 | — |
| +1 | K191598 | AOS ES Retrograde Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K012190 | Aos Modular Femoral NailSummary page 1…Rod DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICE: AOS Modular Femoral Nail System (510(k): K012190, Cleared September 24, 2001), Stryker T2 Supracondylar Nail System (510(k): K023267,… | 2001 |
| * | K023267 | T2 Supracondylar Nail SystemSummary page 1…al Nail System (510(k): K012190, Cleared September 24, 2001), Stryker T2 Supracondylar Nail System (510(k): K023267, Cleared December 11, 2002), and AOS Antegrade Femoral Nail System… | 2002 |
| * | K123569 | Antegrade Femoral NailSummary page 1…ar Nail System (510(k): K023267, Cleared December 11, 2002), and AOS Antegrade Femoral Nail System (510(k): K123569, Cleared May 24, 2013) DEVICE DESCRIPTION: The AOS Retrograde Femoral Nail System consi… | 2013 |
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 16 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K133081 (Advanced Orthopaedic Solutions, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K012190.
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. 2013, 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 Retrograde 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 prosthesis
Fractures distal to a hip joint
Nonunions and malunions
Fractures resulting from osteoporosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132005 · printed Nov 3, 2026
Cite this page
510(k) Report. “K132005: Retrograde Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132005
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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