510(k) · Cleared
ClearedARIX Diaphysis 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 Jul 24, 2017 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 3 other predicates after an 84-day review. Its family tree reaches back 9 generations to 1996. 6 later devices descend from it.
- Decided
- Jul 24, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K962616 (1996). 31 ancestors in all, the oldest K885250 (1989). 6 later devices descend from it, 2 citing it directly.
- 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 deviceK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- Descendant · cites it directly · 3 of its ownK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- Descendant · cites it directly · 1 of its ownK180972 ARIX Clavicle SystemJeil Medical Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK230938 ARIX Humerus SystemJeil Medical Corporation · 2023
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 deviceK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172008ARIX Humerus SystemJeil Medical Corporation · 2017 · cites it directly3descendants
- K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020 · 2 generations on1descendant
- K180972ARIX Clavicle SystemJeil Medical Corporation · 2018 · cites it directly1descendant
- K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024 · 3 generations on0descendants
- K230938ARIX Humerus SystemJeil Medical Corporation · 2023 · 2 generations on0descendants
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) | K171285 | ARIX Diaphysis System | Jeil Medical Corporation | 2017 | — |
| +1 | K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 | — |
| +2 | K202912 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2020 | — |
| +1 | K180972 | ARIX Clavicle System | Jeil Medical Corporation | 2018 | — |
| +3 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
| +2 | 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 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 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 |
| 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 |
|---|---|---|---|
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 5…s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; - Primary Predicate Device 510(k) Number: K011335 Device Name: Synthes one-third Tubular DCL Plate - Additional Predicate Devices 510(k) Number:… | 2001 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…: K011335 Device Name: Synthes one-third Tubular DCL Plate - Additional Predicate Devices 510(k) Number: K000684 Device Name: Synthes Small Fragment Dynamic Compression Locking (D… | 2000 |
| * | K112560 | Aptus (R) Distal Humerus SystemSummary page 5…evice Name: Synthes Small Fragment Dynamic Compression Locking (DCL) System 510(k) Number: K112560 Device Name: Aptus® Distal Humerus System 510(k) Number: K082300 Device… | 2011 |
| * | K082300 | Anatomic Locking Plating SystemSummary page 5…ing (DCL) System 510(k) Number: K112560 Device Name: Aptus® Distal Humerus System 510(k) Number: K082300 Device Name: Anatomic Locking Plating System - Reference Predicate Devices 510(k) Number:… | 2009 |
| † | K112812 | Leforte Neuro System Bone Plate | 2012 |
| † | K151468 | ARIX Wrist System | 2016 |
| † | K131311 | Arix Foot System | 2013 |
| † | K132876 | Arix Hand Locking System | 2013 |
What descends from it? (6)
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.
- 10 of the 31 ancestors have a recall of any class.
- Of its descendants, K172008 (Jeil Medical Corporation, 2017) has gone furthest, with 3 descendants of its own.
- 42 other devices also cite its predicate K011335.
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 Diaphysis System is intended for intended for fixation of fractures, osteotomies,
and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia,
fibula, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171285: ARIX Diaphysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171285
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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