510(k) · Cleared
ClearedARIX Wrist 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 12, 2019 as substantially equivalent to K170705 (Jeil Medical Corporation, 2017) and 6 other predicates after a 111-day review. Its family tree reaches back 12 generations to 1979.
- Decided
- Nov 12, 2019
- Review
- 111 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K792022 (1979). 102 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 2 generations backK130116 Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013
- 1 generation backK180972 ARIX Clavicle SystemJeil Medical Corporation · 2018
- This deviceK191972 ARIX Wrist SystemJeil Medical Corporation · 2019
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 5 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 4 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 3 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 2 generations backK130116 Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013
- 1 generation backK180972 ARIX Clavicle SystemJeil Medical Corporation · 2018
- This deviceK191972 ARIX Wrist SystemJeil Medical Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −5 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −4 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −3 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −2 | K130116 | Superior Lateral Variax Clavicle Plate | Stryker Trauma AG | 2013 | — |
| −1 | K180972 | ARIX Clavicle System | Jeil Medical Corporation | 2018 | — |
| 0 (this device) | K191972 | ARIX Wrist System | Jeil Medical Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K170705 | ARIX Wrist SystemSummary page 5…] K191972 Page 2 of 4 The identified predicate devices within this submission are shown as follow; Primary Predicate K170705 - ARIX Wrist System Jeil Medical Corporation Additional Predicates K151468 -… | 2017 |
| * | K151468 | ARIX Wrist SystemSummary page 5…ow; Primary Predicate K170705 - ARIX Wrist System Jeil Medical Corporation Additional Predicates K151468 - ARIX Wrist System Jeil Medical Corporation K161746 -… | 2016 |
| * | K161746 | ARIX Hand SystemSummary page 5…ion Additional Predicates K151468 - ARIX Wrist System Jeil Medical Corporation K161746 - ARIX Hand System Jeil Medical Corporation K050932 -… | 2016 |
| * | K050932 | Distal Volar Radius Anatomical Plate SystemSummary page 5…tion K161746 - ARIX Hand System Jeil Medical Corporation K050932 - DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM HAND INNOVATIONS, INC.… | 2005 |
| * | K092247 | Synthes Locking Hand PlatesSummary page 5…K050932 - DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM HAND INNOVATIONS, INC. K092247 - Synthes Locking Hand Plates Synthes (USA) K062498 -… | 2009 |
| * | K062498 | Profyle SystemSummary page 5…INC. K092247 - Synthes Locking Hand Plates Synthes (USA) K062498 - Profyle System Howmedica Osteonics Corp Reference Predicates K180972 – AR… | 2006 |
| * | K180972 | ARIX Clavicle SystemSummary page 5…(USA) K062498 - Profyle System Howmedica Osteonics Corp Reference Predicates K180972 – ARIX Clavicle System Jeil Medical Corporation There are no significant differences be… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 102 ancestors have a recall of any class.
- 1 other device also cites its predicate K170705.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis.
The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191972: ARIX Wrist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191972
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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