510(k) · Cleared
ClearedARIX Wrist 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 Sep 21, 2017 as substantially equivalent to K151468 (Jeil Medical Corporation, 2016) and 2 other predicates after a 197-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Sep 21, 2017
- Review
- 197 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K962616 (1996). 27 ancestors in all, the oldest K885250 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 3 generations backK103332 Aptus Ulna PlatesMedartis AG · 2011
- 2 generations backK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- 1 generation backK151468 ARIX Wrist SystemJeil Medical Corporation · 2016
- This deviceK170705 ARIX Wrist SystemJeil Medical Corporation · 2017
- Descendant · cites it directly · 1 of its ownK180972 ARIX Clavicle SystemJeil Medical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK191972 ARIX Wrist SystemJeil Medical Corporation · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −3 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| −2 | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| −1 | K151468 | ARIX Wrist System | Jeil Medical Corporation | 2016 | — |
| 0 (this device) | K170705 | ARIX Wrist System | Jeil Medical Corporation | 2017 | — |
| +1 | K180972 | ARIX Clavicle System | Jeil Medical Corporation | 2018 | — |
| +1 | K191972 | ARIX Wrist System | Jeil Medical Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K151468 | ARIX Wrist SystemSummary page 4…)(3)] The identified predicate devices within this submission are shown as follow; 510(k) Number: K151468 Applicant: Jeil Medical Corporation Device Name:… | 2016 |
| * | K092247 | Synthes Locking Hand PlatesSummary page 5…Tel : +82 2 850 3533 / Fax : +82 2 850 3535 510(k) Number: K092247 Applicant: Synthes Device Name: Synthes Locking H… | 2009 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 5…licant: Synthes Device Name: Synthes Locking Hand Plates 510(k) Number: K102694 Applicant: Synthes Device Name: Synthes 2.4mm Var… | 2010 |
| † | K112812 | Leforte Neuro System Bone Plate | 2012 |
| † | K131311 | Arix Foot System | 2013 |
| † | K132876 | Arix Hand Locking System | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 27 ancestors have a recall of any class.
- Of its descendants, K180972 (Jeil Medical Corporation, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K151468.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170705: ARIX Wrist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170705
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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