510(k) · Cleared
ClearedAragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ideatrics, Inc. · DZK Wire, Fixation, Intraosseous
Cleared on Nov 15, 2002 after an 81-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Nov 15, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- DZK
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK022821 Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22…Ideatrics, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- Descendant · 2 generations on · 10 of its ownK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- Descendant · 2 generations on · 5 of its ownK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · 3 generations on · 4 of its ownK141165 Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014
- Descendant · 3 generations on · 2 of its ownK173320 KLS Martin L1 MMF SystemKLS Martin L.P. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K061271Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006 · cites it directly13descendants
- K122313Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012 · 2 generations on10descendants
- K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015 · 2 generations on5descendants
- K141165Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014 · 3 generations on4descendants
- K173320KLS Martin L1 MMF SystemKLS Martin L.P. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022821 | Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge… | Ideatrics, Inc. | 2002 | — |
| +1 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| +2 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| +2 | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +3 | K141165 | Matrixwave MMF System | Synthes (USA) Products, LLC | 2014 | — |
| +3 | K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 DZK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | — | Intraosseous Fixation Wire by Synthes Named without a submission number | |
| * | — | Intraosseous Fixation Wire by Biomet-Kirschner Named without a submission number | |
| * | — | Intraosseous Fixation Wire by Stryker Instruments Named without a submission number | |
| * | — | Intraosseous Fixation Wire by Dupuy International Ltd. Named without a submission number | |
| * | — | Intraosseous Fixation Wire by Zimmer, Inc. Named without a submission number | |
| * | — | Intraosseous Fixation Wire by Mathys Medical Ltd. Named without a submission number |
What descends from it? (14)
See all 142 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?
- Of its descendants, K061271 (KLS-Martin L.P., 2006) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DZK devicesDZK Wire, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DZK
Too few DZK 510(k)s in any year since 2007 to give a median.
Recalls per year · DZK
No recall names DZK since 2007.
Adverse event reports per year · DZK
2in 2021
MAUDE reports naming product code DZK, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022821: Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022821
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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