510(k) · Cleared
ClearedTrochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N
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 Dec 31, 2013 as substantially equivalent to K123569 (Advanced Orthopaedic Solutions, Inc., 2013) and 8 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 31, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K970097 (1997). 40 ancestors in all, the oldest K871539 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 4 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 3 generations backK021008 Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. · 2002 · Recalled
- 2 generations backK103533 ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011
- 1 generation backK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
- This deviceK133081 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −5 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −4 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −3 | K021008 | Advanced Orthopaedic Solutions Trochanteric Nail | Advanced Orthopaedic Solutions, Inc. | 2002 | 12 |
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (9)
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 |
|---|---|---|---|
| * | K123569 | Antegrade Femoral NailSummary page 1…Class 11,21 CFR 888.3020 Intramedullary fixation rod DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICE: AOS Antegrade Femoral Nail (K123569, 5/24/13) AOS Retrograde Femoral Nail (K132005, 9/10/13) AOS Humeral Na… | 2013 |
| * | K132005 | Retrograde Femoral NailSummary page 1…: HSB SUBSTANTIALLY EQUIVALENT DEVICE: AOS Antegrade Femoral Nail (K123569, 5/24/13) AOS Retrograde Femoral Nail (K132005, 9/10/13) AOS Humeral Nail (K050241, 3/14/05) AOS Proximal Humeral Nail… | 2013 |
| * | K050241 | Aos Humeral NailSummary page 1…AOS Antegrade Femoral Nail (K123569, 5/24/13) AOS Retrograde Femoral Nail (K132005, 9/10/13) AOS Humeral Nail (K050241, 3/14/05) AOS Proximal Humeral Nail (K090478, 3/26/09) AOS Tibia[ Nail… | 2005 |
| * | K090478 | Aos Proximal Humeral NailSummary page 1…AOS Retrograde Femoral Nail (K132005, 9/10/13) AOS Humeral Nail (K050241, 3/14/05) AOS Proximal Humeral Nail (K090478, 3/26/09) AOS Tibia[ Nail (K070444, 6/14/07) AOS 12mm and 13mm Tibial N… | 2009 |
| * | K070444 | Aos Tibial NailSummary page 1…AOS Humeral Nail (K050241, 3/14/05) AOS Proximal Humeral Nail (K090478, 3/26/09) AOS Tibia[ Nail (K070444, 6/14/07) AOS 12mm and 13mm Tibial Nails (K130625, 3/28/13) AOS Trochan… | 2007 |
| * | K130625 | 12MM and 13MM Tibial NailsSummary page 1…AOS Proximal Humeral Nail (K090478, 3/26/09) AOS Tibia[ Nail (K070444, 6/14/07) AOS 12mm and 13mm Tibial Nails (K130625, 3/28/13) AOS Trochanteric Nail (K021008, 6/20/02) AOS ES Trochanteric… | 2013 |
| * | K021008 | Advanced Orthopaedic Solutions Trochanteric NailSummary page 1…AOS Tibia[ Nail (K070444, 6/14/07) AOS 12mm and 13mm Tibial Nails (K130625, 3/28/13) AOS Trochanteric Nail (K021008, 6/20/02) AOS ES Trochanteric Nail (K103533, 1/19/11) AOS Solid Locking… | 2002 |
| * | K103533 | ES Trochanteric Nail, Left and Right, 10MMSummary page 1…2mm and 13mm Tibial Nails (K130625, 3/28/13) AOS Trochanteric Nail (K021008, 6/20/02) AOS ES Trochanteric Nail (K103533, 1/19/11) AOS Solid Locking and Telescoping Lag Screw (K120148, 10/2/12… | 2011 |
| * | K120148 | Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewSummary page 1…AOS ES Trochanteric Nail (K103533, 1/19/11) AOS Solid Locking and Telescoping Lag Screw (K120148, 10/2/12) DEVICE DESCRIPTION: AOS Nails are iritramedullary fixation devices for the tempor… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230257 | Arthrex Intramedullary Nails | 2023 | 1 |
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 3 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 40 ancestors have a recall of any class.
- Of its descendants, K230257 (Arthrex, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K123569.
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 Antegrade and Retrograde Femoral Nail are 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 intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures…
Read the full statement (271 words)
The AOS Antegrade and Retrograde Femoral Nail are 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 intraarticular 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.
The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.
The AOS Tibial Nail 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.
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, pertrochanteric 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 revision procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133081: Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133081
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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