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 Jan 13, 2025 as substantially equivalent to K230257 (Arthrex, Inc., 2023) after a 26-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Jan 13, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K970097 (1997). 103 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 7 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 6 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 5 generations backK021008 Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. · 2002 · Recalled
- 4 generations backK103533 ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011
- 3 generations backK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
- 2 generations backK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
- 1 generation backK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
- This deviceK243890 Arthrex Intramedullary NailsArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −7 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −6 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −5 | K021008 | Advanced Orthopaedic Solutions Trochanteric Nail | Advanced Orthopaedic Solutions, Inc. | 2002 | 12 |
| −4 | K103533 | ES Trochanteric Nail, Left and Right, 10MM | Advanced Orthopaedic Solutions, Inc. | 2011 | — |
| −3 | K120148 | Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw | Advanced Orthopaedic Solutions, Inc. | 2012 | — |
| −2 | K133081 | Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails… | Advanced Orthopaedic Solutions, Inc. | 2013 | — |
| −1 | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K230257 | Arthrex Intramedullary NailsSummary page 5…llary and Accessories Product Code HSB Classification Name 21 CFR 888.3020: Intramedullary Fixation Rod Regulatory Class II Predicate Device K230257: Arthrex Intramedullary Nails Reference Device K132217: Arthrex Compression FT Screws K233134: I.T… | 2023 |
| † | K132217 | Arthrex Compression FT Screws | 2013 |
| † | K233134 | I.T.S. INS Proximal Femur Nail | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 38 of the 103 ancestors have a recall of any class.
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. 2025, 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 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…
Read the full statement (100 words)
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 as stated in the FDA summary.
https://510kreport.com/device/K243890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243890: Arthrex Intramedullary Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243890
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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