510(k) · Cleared
ClearedARIX Foot System (2.3/2.8)
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 14, 2017 as substantially equivalent to K052614 (Arthrex, Inc., 2005) and 1 other predicate after a 152-day review. Its family tree reaches back 6 generations to 2000. 4 later devices descend from it.
- Decided
- Aug 14, 2017
- Review
- 152 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000684 (2000). 41 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 2 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 1 generation backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- This deviceK170780 ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017
- Descendant · cites it directly · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · cites it directly · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · cites it directly · 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 4 of 4 · See all- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · cites it directly3descendants
- K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · cites it directly1descendant
- K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022 · cites it directly0descendants
- 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 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −2 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −1 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K170780 | ARIX Foot System (2.3/2.8) | Jeil Medical Corporation | 2017 | — |
| +1 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +1 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +1 | 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 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K052614 | Low Profile Plate and Screw SystemSummary page 5…The identified predicate devices within this submission are shown as follow; - Predicate Devices 510(k) Number: K052614 Device Name: Low Profile Plate and Screw System 510(k) Number:… | 2005 |
| * | K131311 | Arix Foot SystemSummary page 5…K052614 Device Name: Low Profile Plate and Screw System 510(k) Number: K131311 Device Name: ARIX Foot System - Reference Predicate Devices… | 2013 |
| † | K112812 | Leforte Neuro System Bone Plate | 2012 |
| † | K151468 | ARIX Wrist System | 2016 |
| † | K132876 | Arix Hand Locking System | 2013 |
What descends from it? (4)
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 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K180808 (Extremity Medical, LLC, 2018) has gone furthest, with 3 descendants of its own.
- 12 other devices also cite its predicate K052614.
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 Foot System (2.3/2.8) 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 fusion, corrective osteotomies, and the treatment of fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170780: ARIX Foot System (2.3/2.8).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170780
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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