510(k) · Cleared
ClearedARIX Femur Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 10, 2025 as substantially equivalent to K200869 (Stryker Trauma GmbH, 2020) and 3 other predicates after a 96-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Dec 10, 2025
- Review
- 96 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K953730 (1995). 116 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 6 generations between
- 3 generations backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK192314 RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019
- 1 generation backK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
- This deviceK252826 ARIX Femur Nail SystemJeil Medical Corporation · 2025
Show all 10 generations
- Root · 10 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 9 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 8 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 7 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 6 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 5 generations backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- 4 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK192314 RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019
- 1 generation backK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
- This deviceK252826 ARIX Femur Nail SystemJeil Medical Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −9 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −8 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −7 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −6 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −5 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| −4 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −2 | K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | 2019 | — |
| −1 | K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024 | — |
| 0 (this device) | K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K200869 | Gamma3 SystemSummary page 6…ion of Predicate Device(s) [21 CFR 807.92(a)(3)] The legally marketed device(s) to which substantial equivalence is claimed is/are: Primary Predicate Device K200869 - Gamma3 System, Stryker Trauma GmbH Reference Device K242247 – ARIX Femur Nail System,… | 2020 |
| * | K242247 | ARIX Femur Nail SystemSummary page 6…(s) to which substantial equivalence is claimed is/are: Primary Predicate Device K200869 - Gamma3 System, Stryker Trauma GmbH Reference Device K242247 – ARIX Femur Nail System, Jeil Medical Corporation… | 2025 |
| * | K231251 | FlexWing Anterior Cervical Plate SystemSummary page 6…Reference Device K242247 – ARIX Femur Nail System, Jeil Medical Corporation K231251 - FlexWing Anterior Cervical Plate System, Jeil Medical Corporation… | 2024 |
| * | K202099 | AOS Galileo™ Trochanteric Nail SystemSummary page 6…K231251 - FlexWing Anterior Cervical Plate System, Jeil Medical Corporation K202099 - AOS Galileo™ Trochanteric Nail System, Advanced Orthopaedic Solutions, Inc. Th… | 2020 |
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 30 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- 33 of the 116 ancestors have a recall of any class.
- 5 other devices also cite its predicate K200869.
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?
ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for
stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric
and shaft regions of the femur (including osteoporotic and osteopenic bone).
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/K252826 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252826: ARIX Femur Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252826
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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