510(k) · Cleared
ClearedArix Hand 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 Nov 4, 2013 as substantially equivalent to K062498 (Howmedica Osteonics Corp., 2006) after a 158-day review. Its family tree reaches back 6 generations to 1996. 8 later devices descend from it.
- Decided
- Nov 4, 2013
- Review
- 158 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962616 (1996). 17 ancestors in all, the oldest K885250 (1989). 8 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 1 generation backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- This deviceK131566 Arix Hand SystemJeil Medical Corporation · 2013
- Descendant · cites it directly · 3 of its ownK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK221558 ALPHALOK Plating SystemVilex, LLC · 2022
- Descendant · cites it directly · 1 of its ownK192417 ARIX Cannulated Screw SystemJeil Medical Corporation · 2019
- Descendant · cites it directly · 1 of its ownK161746 ARIX Hand SystemJeil Medical Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK233816 REDEMPTION Charcot Plating SystemVilex, LLC · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K212348ALPHALOK™ Plating SystemVilex, LLC · 2022 · cites it directly3descendants
- K221558ALPHALOK Plating SystemVilex, LLC · 2022 · 2 generations on2descendants
- K192417ARIX Cannulated Screw SystemJeil Medical Corporation · 2019 · cites it directly1descendant
- K161746ARIX Hand SystemJeil Medical Corporation · 2016 · cites it directly1descendant
- K233816REDEMPTION Charcot Plating SystemVilex, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −5 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −4 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −1 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| 0 (this device) | K131566 | Arix Hand System | Jeil Medical Corporation | 2013 | — |
| +1 | K212348 | ALPHALOK™ Plating System | Vilex, LLC | 2022 | — |
| +2 | K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 | — |
| +1 | K192417 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2019 | — |
| +1 | K161746 | ARIX Hand System | Jeil Medical Corporation | 2016 | — |
| +3 | K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K062498 | Profyle SystemSummary page 1…- Bone plate & screw Classification Name - Single/multiple component metallic bone fixation appliances and accessories 3. Predicate Device: Profyle System, K062498, Howmredica Osteonics Corp. 4. Classifications Names & Citations: Orthopedic HRS, 2ICFRSSS.3030 5. Description:… | 2006 |
What descends from it? (8)
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?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K212348 (Vilex, LLC, 2022) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K062498.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Hand System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131566: Arix Hand System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131566
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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