510(k) · Cleared
ClearedARIX Ankle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 28, 2015 as substantially equivalent to K081284 (Howmedica Osteonics Corp., 2008) after a 56-day review. Its family tree reaches back 1 generation to 2008. 6 later devices descend from it.
- Decided
- Sep 28, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081284 (2008). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK081284 Variax Distal Fibula PlateHowmedica Osteonics Corp. · 2008
- This deviceK152158 ARIX Ankle SystemJeil Medical Corporation · 2015
- Descendant · cites it directly · 3 of its ownK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK230938 ARIX Humerus SystemJeil Medical Corporation · 2023
- Descendant · cites it directly · 0 of its ownK193616 ARIX Ankle SystemJeil Medical Corporation · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172008ARIX Humerus SystemJeil Medical Corporation · 2017 · cites it directly3descendants
- K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020 · 2 generations on1descendant
- K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024 · 3 generations on0descendants
- K230938ARIX Humerus SystemJeil Medical Corporation · 2023 · 2 generations on0descendants
- K193616ARIX Ankle SystemJeil Medical Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081284 | Variax Distal Fibula Plate | Howmedica Osteonics Corp. | 2008 | — |
| 0 (this device) | K152158 | ARIX Ankle System | Jeil Medical Corporation | 2015 | — |
| +1 | K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 | — |
| +2 | K202912 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2020 | — |
| +3 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
| +2 | K230938 | ARIX Humerus System | Jeil Medical Corporation | 2023 | — |
| +1 | K193616 | ARIX Ankle System | Jeil Medical Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 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 |
|---|---|---|---|
| * | K081284 | Variax Distal Fibula PlateSummary page 5…dicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; 510(k) Number: Applicant: Common Name: Device Name: K081284 HOWMEDICA OSEONICS CORP. plate, fixation, bone VariAX™ Distal Fibula Plate There are no significant differences between the Mo… | 2008 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.
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/K152158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152158: ARIX Ankle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152158
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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