510(k) · Cleared
ClearedARIX Humerus 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 Dec 1, 2017 as substantially equivalent to K011815 (Synthes (Usa), 2001) and 3 other predicates after a 151-day review. Its family tree reaches back 10 generations to 1996. 3 later devices descend from it.
- Decided
- Dec 1, 2017
- Review
- 151 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K962616 (1996). 38 ancestors in all, the oldest K885250 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- 2 generations backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- 1 generation backK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- This deviceK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- Descendant · cites it directly · 1 of its ownK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK230938 ARIX Humerus SystemJeil Medical Corporation · 2023
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 5 generations backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 4 generations backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- 3 generations backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- 2 generations backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- 1 generation backK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- This deviceK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −5 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| −4 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| −3 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| −2 | K112560 | Aptus (R) Distal Humerus System | Medartis AG | 2011 | — |
| −1 | K171285 | ARIX Diaphysis System | Jeil Medical Corporation | 2017 | — |
| 0 (this device) | K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 | — |
| +1 | K202912 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2020 | — |
| +2 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
| +1 | K230938 | ARIX Humerus System | Jeil Medical Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 4…4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within submission are shown as follows: z 510(k) Number: K011815 z Applicant: Synthes (USA) z Device Name: SYNTHES LCP PROXIMAL HUMERUS PLATES… | 2001 |
| * | K171285 | ARIX Diaphysis System Cleared while this submission was under review Summary page 5…34-gil, Guro-gu, 08378, Korea Tel : +82 2 850 3533 / Fax : +82 2 850 3536 z 510(k) Number: K171285 z Applicant: Jeil Medical Corporation z Common Name: Bone Plate, Bone Screw z Device Name: ARIX Diaphy… | 2017 |
| * | K151468 | ARIX Wrist SystemSummary page 5…rporation z Common Name: Bone Plate, Bone Screw z Device Name: ARIX Diaphysis System - Reference Predicate Device z 510(k) Number: K151468 z Applicant: Jeil Medical Corporation z Common Name: Bone Plate, Bone Screw z Device Name: ARIX Wrist… | 2016 |
| * | K152158 | ARIX Ankle SystemSummary page 5…K151468 z Applicant: Jeil Medical Corporation z Common Name: Bone Plate, Bone Screw z Device Name: ARIX Wrist System z 510(k) Number: K152158 z Applicant: Jeil Medical Corporation z Common Name: Bone Plate, Bone Screw z Device Name: ARIX Ankle… | 2015 |
What descends from it? (3)
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 7 companies; a new generation was cleared every 2.1 years on median.
- 11 of the 38 ancestors have a recall of any class.
- Of its descendants, K202912 (Jeil Medical Corporation, 2020) has gone furthest, with 1 descendant of its own.
- 24 other devices also cite its predicate K011815.
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?
ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172008: ARIX Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172008
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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