510(k) · Cleared
ClearedARIX Elbow 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 15, 2020 as substantially equivalent to K090053 (Medartis AG, 2009) and 3 other predicates after an 89-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Sep 15, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K962616 (1996). 29 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- 2 generations backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- 1 generation backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- This deviceK201656 ARIX Elbow SystemJeil Medical Corporation · 2020
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 4 generations backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 3 generations backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- 2 generations backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- 1 generation backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- This deviceK201656 ARIX Elbow SystemJeil Medical Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −4 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| −3 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| −2 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| −1 | K112560 | Aptus (R) Distal Humerus System | Medartis AG | 2011 | — |
| 0 (this device) | K201656 | ARIX Elbow System | Jeil Medical Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K090053 | Aptus 2.0 Radial Head SystemSummary page 5…on of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission are shown as follow; Primary Predicate K090053 – APTUS 2.0 Radial Head System Medartis AG Additional Predicates K103332… | 2009 |
| * | K103332 | Aptus Ulna PlatesSummary page 5…Primary Predicate K090053 – APTUS 2.0 Radial Head System Medartis AG Additional Predicates K103332 – APTUS Ulna Plates Medartis AG K112560 – APTUS Dis… | 2011 |
| * | K112560 | Aptus (R) Distal Humerus SystemSummary page 5…Medartis AG Additional Predicates K103332 – APTUS Ulna Plates Medartis AG K112560 – APTUS Distal Humerus System Medartis AG K063049 –… | 2011 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 5…AG K112560 – APTUS Distal Humerus System Medartis AG K063049 – Synthes Modular Mini Fragment LCP System Synthes (USA) Reference Device K1… | 2006 |
| † | K170705 | ARIX Wrist System | 2017 |
| † | K170313 | ARIX Ankle Distal Tibia System | 2017 |
| † | K171285 | ARIX Diaphysis System | 2017 |
| † | K172008 | ARIX Humerus System | 2017 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 29 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090053.
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 Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humerus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201656 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201656: ARIX Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201656
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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