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 Oct 29, 2020 as substantially equivalent to K170313 (Jeil Medical Corporation, 2017) and 2 other predicates after a 30-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Oct 29, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K962616 (1996). 74 ancestors in all, the oldest K885250 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- 2 generations backK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- 1 generation backK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- This deviceK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- Descendant · cites it directly · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 6 generations backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 5 generations backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- 4 generations backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- 3 generations backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- 2 generations backK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- 1 generation backK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- This deviceK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −6 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| −5 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| −4 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| −3 | K112560 | Aptus (R) Distal Humerus System | Medartis AG | 2011 | — |
| −2 | K171285 | ARIX Diaphysis System | Jeil Medical Corporation | 2017 | — |
| −1 | K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 | — |
| 0 (this device) | K202912 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2020 | — |
| +1 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1998 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K170313 | ARIX Ankle Distal Tibia SystemSummary page 5…ification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission are shown as follow; Primary Predicate K170313 - ARIX Ankle Distal Tibia System Jeil Medical Corporation Other Predicates… | 2017 |
| * | K172008 | ARIX Humerus SystemSummary page 5…ary Predicate K170313 - ARIX Ankle Distal Tibia System Jeil Medical Corporation Other Predicates K172008 - ARIX Humerus System Jeil Medical Corporation K001945… | 2017 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 5…n Other Predicates K172008 - ARIX Humerus System Jeil Medical Corporation K001945 - SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES SYNTEHS(USA) There are no significant differ… | 2000 |
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 |
|---|---|---|---|
| K232115 | TDM Large Bone Plate and Screw System | 2024 | 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 24 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 17 of the 74 ancestors have a recall of any class.
- Of its descendants, K232115 (Tdm Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202912 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202912: 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/K202912
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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