510(k) · Cleared
ClearedARIX Foot 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 Aug 2, 2016 as substantially equivalent to K063875 (Howmedica Osteonics Corp., 2007) and 1 other predicate after a 26-day review. Its family tree reaches back 6 generations to 1996. 5 later devices descend from it.
- Decided
- Aug 2, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K953806 (1996). 27 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 5 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 4 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 3 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 2 generations backK112457 Leforte System Bone Plate & ScrewArkin Consulting Group · 2012
- 1 generation backK131311 Arix Foot SystemJeil Medical Corporation · 2013
- This deviceK161864 ARIX Foot SystemJeil Medical Corporation · 2016
- Descendant · cites it directly · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- Descendant · cites it directly · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · 2 generations on · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK221362 Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK192592 Axis Plating SystemExtremity Medical, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · cites it directly4descendants
- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · cites it directly3descendants
- K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · 2 generations on1descendant
- K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022 · 3 generations on0descendants
- K192592Axis Plating SystemExtremity Medical, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −5 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −4 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −3 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −2 | K112457 | Leforte System Bone Plate & Screw | Arkin Consulting Group | 2012 | — |
| −1 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| 0 (this device) | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
| +1 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
| +1 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +2 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +3 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | — |
| +2 | K192592 | Axis Plating System | Extremity Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K063875 | Stryker Foot Plating SystemSummary page 5…ation of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follows: x 510(k) Number: K063875 x Applicant: Howmedica Osteonics Corp. x Common Name: Plate, Fixation, Bone x De… | 2007 |
| * | K131311 | Arix Foot SystemSummary page 5…nics Corp. x Common Name: Plate, Fixation, Bone x Device Name: Stryker Foot Plating System x 510(k) Number: K131311 x Applicant: Jeil Medical Corporation x Common Name: Plate, Fixation, Bone x Dev… | 2013 |
What descends from it? (5)
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 20 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K172260 (Extremity Medical, LLC, 2017) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K063875.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Foot System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. 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/K161864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161864: ARIX Foot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161864
Report an extraction error
Are you the manufacturer?
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