510(k) · Cleared
Recalled · 2010Advanced Orthopaedic Solutions Trochanteric 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 20, 2002 as substantially equivalent to K010780 (DePuy Orthopaedics, Inc., 2001) and 7 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1997. 13 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 20, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 12
- Predicates
- 8
Its longest line of descent runs back 3 generations to K970097 (1997). 12 ancestors in all, the oldest K871539 (1987). 13 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 2 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 1 generation backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- This deviceK021008 Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. · 2002
- Descendant · cites it directly · 11 of its ownK103533 ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK202099 AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK140601 Flow-NailFlow-Fx, LLC · 2014
- Descendant · cites it directly · 2 of its ownK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011 · cites it directly11descendants
- K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012 · cites it directly6descendants
- K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc. · 2020 · cites it directly4descendants
- K140601Flow-NailFlow-Fx, LLC · 2014 · cites it directly2descendants
- K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc. · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −2 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −1 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| 0 (this device) | K021008 | Advanced Orthopaedic Solutions Trochanteric Nail | Advanced Orthopaedic Solutions, Inc. | 2002 | — |
| +1 | K103533 | ES Trochanteric Nail, Left and Right, 10MM | Advanced Orthopaedic Solutions, Inc. | 2011 | — |
| +1 | K120148 | Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw | Advanced Orthopaedic Solutions, Inc. | 2012 | — |
| +1 | K202099 | AOS Galileo™ Trochanteric Nail System | Advanced Orthopaedic Solutions, Inc. | 2020 | — |
| +1 | K140601 | Flow-Nail | Flow-Fx, LLC | 2014 | — |
| +1 | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (8)
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 |
|---|---|---|---|
| * | K010780 | Trochanteric Nail | 2001 |
| * | K013563 | Long Trochanteric Nail System | 2001 |
| * | K993670 | Modified Long Length Gamma NailSummary page 1…ing devices. DePuy ACE, Trochanteric Nails KO10780 and KO13563 Howmedica Osteonics, Gamma Nails K993670, KO12158 and KO13524 Smith and Nephew, zntrameduliaryHip Screw K 912162, K921786 and IC954712… | 1999 |
| * | K012158 | Modification to: Long Length Gamma Nail | 2001 |
| * | K013524 | Trochanteric Dyax Nail System | 2001 |
| * | K912162 | Intramedullary Hip Screw, ModificationSummary page 1…3563 Howmedica Osteonics, Gamma Nails K993670, KO12158 and KO13524 Smith and Nephew, zntrameduliaryHip Screw K 912162, K921786 and IC954712 -2- DEPARTMENT OF HEALTH & HUMAN SERVIC… | 1991 |
| * | K921786 | Intramedullary Hip ScrewSummary page 1…Howmedica Osteonics, Gamma Nails K993670, KO12158 and KO13524 Smith and Nephew, zntrameduliaryHip Screw K 912162, K921786 and IC954712 -2- DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1992 |
| * | K954712 | Intramedullary Hip Screw (Modification)Summary page 1…steonics, Gamma Nails K993670, KO12158 and KO13524 Smith and Nephew, zntrameduliaryHip Screw K 912162, K921786 and IC954712 -2- DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1995 |
What descends from it? (13)
See all 137 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103533 | ES Trochanteric Nail, Left and Right, 10MM | 2011 | 11 |
| K120148 | Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw | 2012 | 6 |
| K202099 | AOS Galileo™ Trochanteric Nail System | 2020 | 4 |
| K140601 | Flow-Nail | 2014 | 2 |
| K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade… | 2013 | 2 |
| K230257 | Arthrex Intramedullary Nails | 2023 | 1 |
| K042440 | Alphatec Femoral Trochanteric Nail (FTN) System | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2010 | Not classified | Z-1190-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1187-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1184-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1182-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1188-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1186-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-118-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1189-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1183-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1181-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1191-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
| Jan 14, 2010 | Not classified | Z-1192-2010 | Process control | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K103533 (Advanced Orthopaedic Solutions, Inc., 2011) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K010780.
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 Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021008 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021008: Advanced Orthopaedic Solutions Trochanteric Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021008
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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