510(k) · Cleared
ClearedArthrex Intramedullary Nails
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 17, 2023 as substantially equivalent to K133081 (Advanced Orthopaedic Solutions, Inc., 2013) and 8 other predicates after a 167-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Jul 17, 2023
- Review
- 167 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 7 generations to K970097 (1997). 102 ancestors in all, the oldest K871539 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 5 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 4 generations backK021008 Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. · 2002 · Recalled
- 3 generations backK103533 ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011
- 2 generations backK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
- 1 generation backK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
- This deviceK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243890 Arthrex Intramedullary NailsArthrex, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243890Arthrex Intramedullary NailsArthrex, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −6 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −5 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −4 | K021008 | Advanced Orthopaedic Solutions Trochanteric Nail | Advanced Orthopaedic Solutions, Inc. | 2002 | 12 |
| −3 | K103533 | ES Trochanteric Nail, Left and Right, 10MM | Advanced Orthopaedic Solutions, Inc. | 2011 | — |
| −2 | K120148 | Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw | Advanced Orthopaedic Solutions, Inc. | 2012 | — |
| −1 | K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails… | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| 0 (this device) | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
| +1 | K243890 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Summary page 6…HSB Classification Name 21 CFR 888.3020: Intramedullary Fixation Rod Regulatory Class II Primary Predicate Device K133081: AOS Intramedullary Nail Additional Predicate Device(s) K202099: AOS Galileo Trochanteric Nail System… | 2013 |
| * | K202099 | AOS Galileo™ Trochanteric Nail SystemSummary page 6….3020: Intramedullary Fixation Rod Regulatory Class II Primary Predicate Device K133081: AOS Intramedullary Nail Additional Predicate Device(s) K202099: AOS Galileo Trochanteric Nail System K141228: AOS Antegrade Femoral Nail System… | 2020 |
| * | K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous ScrewSummary page 6…Predicate Device K133081: AOS Intramedullary Nail Additional Predicate Device(s) K202099: AOS Galileo Trochanteric Nail System K141228: AOS Antegrade Femoral Nail System K132005: AOS Retrograde Femoral Nail System… | 2014 |
| * | K132005 | Retrograde Femoral NailSummary page 6…te Device(s) K202099: AOS Galileo Trochanteric Nail System K141228: AOS Antegrade Femoral Nail System K132005: AOS Retrograde Femoral Nail System K130625: AOS 12 mm and 13 mm Tibial Nails… | 2013 |
| * | K130625 | 12MM and 13MM Tibial NailsSummary page 6…K141228: AOS Antegrade Femoral Nail System K132005: AOS Retrograde Femoral Nail System K130625: AOS 12 mm and 13 mm Tibial Nails K123569: AOS Antegrade Femoral Nail System… | 2013 |
| * | K123569 | Antegrade Femoral NailSummary page 6…K132005: AOS Retrograde Femoral Nail System K130625: AOS 12 mm and 13 mm Tibial Nails K123569: AOS Antegrade Femoral Nail System K103533: AOS ES Trochanteric Nail… | 2013 |
| * | K103533 | ES Trochanteric Nail, Left and Right, 10MMSummary page 6…K130625: AOS 12 mm and 13 mm Tibial Nails K123569: AOS Antegrade Femoral Nail System K103533: AOS ES Trochanteric Nail K070444: AOS Tibial Nail K021008: Adv… | 2011 |
| * | K070444 | Aos Tibial NailSummary page 6…K123569: AOS Antegrade Femoral Nail System K103533: AOS ES Trochanteric Nail K070444: AOS Tibial Nail K021008: Advanced Orthopaedic Solutions Trochanteric Nail Reference Device(s)… | 2007 |
| * | K021008 | Advanced Orthopaedic Solutions Trochanteric NailSummary page 6…Nail System K103533: AOS ES Trochanteric Nail K070444: AOS Tibial Nail K021008: Advanced Orthopaedic Solutions Trochanteric Nail Reference Device(s) K222267: Arthrex 2.4 mm Volar Distal Radius Pl… | 2002 |
| † | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | 2022 |
| † | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | 2022 |
| † | K213837 | Arthrx Fracture Plates | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243890 | Arthrex Intramedullary Nails | 2025 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 38 of the 102 ancestors have a recall of any class.
- Of its descendants, K243890 (Arthrex, Inc., 2025) has gone furthest, with 0 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. 2023, 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 antegrade 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 (325 words)
The antegrade 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, and fractures resulting from osteoporosis.
The 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, and fractures resulting from osteoporosis.
The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, 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 trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric 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.
The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
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/K230257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230257: Arthrex Intramedullary Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230257
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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