510(k) · Cleared
ClearedArzzt Distal Radius and Ulna System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truemed Group, LLC · HRS Plate, Fixation, Bone
Cleared on Jun 10, 2019 as substantially equivalent to K012114 (Synthes (Usa), 2001) and 4 other predicates after a 259-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Jun 10, 2019
- Review
- 259 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K981372 (1998). 22 ancestors in all, the oldest K962616 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 1 generation backK162507 Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC · 2017
- This deviceK182650 Arzzt Distal Radius and Ulna SystemTruemed Group, LLC · 2019
- Descendant · cites it directly · 0 of its ownK200575 Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −1 | K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments System | Truemed Group, LLC | 2017 | — |
| 0 (this device) | K182650 | Arzzt Distal Radius and Ulna System | Truemed Group, LLC | 2019 | — |
| +1 | K200575 | Truemed Hand, Foot and Ankle Plates System | Truemed Group, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (5)
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 |
|---|---|---|---|
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 4…21 CFR 888.3030 21 CFR 888.3040 10. Predicate Devices: Primary Predicate: Synthes Locking Distal Radius Plating System (K012114) Additional Predicates: Synthes (USA) 3.5ram LCP Hook Plate (K082… | 2001 |
| * | K082072 | Synthes (Usa) 3.5MM LCP Hook PlateSummary page 4…Plating System (K012114) Additional Predicates: Synthes (USA) 3.5ram LCP Hook Plate (K082072) 2.4mmn Variable Angle LCP Dorsal Distal Radius System (K102694)… | 2008 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 4…Synthes (USA) 3.5ram LCP Hook Plate (K082072) 2.4mmn Variable Angle LCP Dorsal Distal Radius System (K102694) Arzzt 3.5 / 4.5 Small & Large Fragments System (K162507)… | 2010 |
| * | K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments SystemSummary page 4…l Radius System (K102694) Arzzt 3.5 / 4.5 Small & Large Fragments System (K162507) Synthes Stainless Steel Modular Hand System (K030310)… | 2017 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 4…e Fragments System (K162507) Synthes Stainless Steel Modular Hand System (K030310) Reference Predicate: Ins Hilden Tibial Arzzt (K133166) 11. Dev… | 2003 |
| † | K133166 | Ins Hilden Tibial Arzzt | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200575 | Truemed Hand, Foot and Ankle Plates System | 2021 | 0 |
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 3 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K200575 (Truemed Group, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K012114.
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 Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182650: Arzzt Distal Radius and Ulna System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182650
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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