510(k) · Cleared
ClearedARIX Ankle Distal Tibia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · HRS Plate, Fixation, Bone
Cleared on Dec 14, 2023 as substantially equivalent to K181067 (Extremity Medical, LLC, 2018) and 1 other predicate after a 170-day review. Its family tree reaches back 15 generations to 1996. 1 later device descends from it.
- Decided
- Dec 14, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K954385 (1996). 218 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 2 generations backK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- 1 generation backK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- This deviceK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
- Descendant · cites it directly · 0 of its ownK252246 Leforte MMF SystemJeil Medical Corporation · 2026
Show all 15 generations
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 13 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 12 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 11 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 10 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 9 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 8 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 7 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 6 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 2 generations backK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- 1 generation backK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- This deviceK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K252246Leforte MMF SystemJeil Medical Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −14 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −13 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −12 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −11 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −10 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −9 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −8 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −7 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −6 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −2 | K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | 2016 | — |
| −1 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | — |
| 0 (this device) | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | — |
| +1 | K252246 | Leforte MMF System | Jeil Medical Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 16 | 0 |
| 1997 | 5 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 12 | 0 |
| 2001 | 20 | 0 |
| 2002 | 18 | 0 |
| 2003 | 9 | 0 |
| 2004 | 8 | 0 |
| 2005 | 16 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K181067 | AlignX Ankle Fusion SystemSummary page 5…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 K181067 – AlignX Ankle Fusion System, Extremity Medical, LLC. Secondary Predicate Device… | 2018 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 5…redicate Device K181067 – AlignX Ankle Fusion System, Extremity Medical, LLC. Secondary Predicate Device K141735 – Arthrex Ankle Fusion Plating System, ARTHREX, INC. Reference Device… | 2014 |
| † | K202912 | ARIX Ankle Distal Tibia System | 2020 |
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 |
|---|---|---|---|
| K252246 | Leforte MMF System | 2026 | 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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 33 of the 218 ancestors have a recall of any class.
- Of its descendants, K252246 (Jeil Medical Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181067.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231887 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231887: ARIX Ankle Distal Tibia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231887
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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