510(k) · Cleared
ClearedDimac Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentations Unltd. · DYX Lock, Wire, And Ligature, Intraoral
Cleared on Jul 25, 1991 after a 197-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jul 25, 1991
- Review
- 197 days
- Class
- Class II
- Product code
- DYX
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK910090 Dimac WiresInstrumentations Unltd. · 1991
- Descendant · cites it directly · 15 of its ownK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- Descendant · 2 generations on · 14 of its ownK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- Descendant · 2 generations on · 13 of its ownK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- Descendant · 3 generations on · 10 of its ownK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- Descendant · 3 generations on · 5 of its ownK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K991004Synthes Quick Lock Imf SystemSynthes (Usa) · 1999 · cites it directly15descendants
- K031207Safety Release Arch Bar KitCasey Surgical, LLC · 2003 · 2 generations on14descendants
- K061271Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006 · 2 generations on13descendants
- K122313Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012 · 3 generations on10descendants
- K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910090 | Dimac Wires | Instrumentations Unltd. | 1991 | — |
| +1 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| +2 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| +2 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| +3 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| +3 | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991004 | Synthes Quick Lock Imf System | 1999 | 15 |
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, K991004 (Synthes (Usa), 1999) has gone furthest, with 15 descendants of its own.
How does its category compare?
All DYX devicesDYX Lock, Wire, And Ligature, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DYX
Too few DYX 510(k)s in any year since 2007 to give a median.
Recalls per year · DYX
No recall names DYX since 2007.
Adverse event reports per year · DYX
1in 2016
MAUDE reports naming product code DYX, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K910090: Dimac Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910090
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026