510(k) · Cleared
ClearedMagellan Intramedullary Femoral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 5, 1997 after a 70-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jun 5, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK971135 Magellan Intramedullary Femoral Nail SystemWrightmedicaltechnologyinc · 1997
- Descendant · cites it directly · 10 of its ownK012190 Aos Modular Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2001
- Descendant · 2 generations on · 6 of its ownK123569 Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK132005 Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · 3 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K012190Aos Modular Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2001 · cites it directly10descendants
- K123569Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013 · 2 generations on6descendants
- K132005Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. · 2013 · 2 generations on4descendants
- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · 2 generations on2descendants
- K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971135 | Magellan Intramedullary Femoral Nail System | Wrightmedicaltechnologyinc | 1997 | — |
| +1 | K012190 | Aos Modular Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2001 | — |
| +2 | K123569 | Antegrade Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +2 | K132005 | Retrograde Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| +2 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +3 | K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous Screw | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | — | MAGELLAN™ Femoral Nail Named without a submission number | |
| * | — | Russell-Taylor Femoral Nail System Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012190 | Aos Modular Femoral Nail | 2001 | 10 |
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?
- Of its descendants, K012190 (Advanced Orthopaedic Solutions, Inc., 2001) has gone furthest, with 10 descendants of its own.
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 MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in
long bone shaft fractures of the femur which require stabilization of the axis of the
bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck
fractures, comminuted fractures, segmental fractures, fractures with bone loss,
proximal and distal fractures, nonunions and malunions, and bone lengthening.
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/K971135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971135: Magellan Intramedullary Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971135
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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