510(k) · Cleared
ClearedSynthes Quick Lock Imf System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · DYX Lock, Wire, And Ligature, Intraoral
Cleared on Jun 23, 1999 as substantially equivalent to K910090 (Instrumentations Unltd., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1982. 15 later devices descend from it.
- Decided
- Jun 23, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- DYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820944 (1982). 2 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK820944 Dental Arch BarUnisplint Corp. · 1982
- This deviceK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- Descendant · cites it directly · 14 of its ownK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- 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
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K031207Safety Release Arch Bar KitCasey Surgical, LLC · 2003 · cites it directly14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| 0 (this device) | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| +1 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (3)
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 |
|---|---|---|---|
| * | K910090 | Dimac WiresSummary page 1…Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Sheri L. Musgnung Lock, Wire, and Ligature, Intraoral Class II, 21 CFR 872.4700 Dimac Medical, Inc. Dimac Wires (K910090) W. Lorenz Traditional Wire and Arch Bars, Unisplint (K820944) Wall-Omnisplint Maxillofacial Fracture Kit (K number unkown) The… | 1991 |
| * | K820944 | Dental Arch BarSummary page 1…. Musgnung Lock, Wire, and Ligature, Intraoral Class II, 21 CFR 872.4700 Dimac Medical, Inc. Dimac Wires (K910090) W. Lorenz Traditional Wire and Arch Bars, Unisplint (K820944) Wall-Omnisplint Maxillofacial Fracture Kit (K number unkown) The Synthes Quick Lock™ IMF System consists of brackets, arch bars… | 1982 |
| * | — | Wall-Omnisplint Maxillofacial Fracture Kit Named without a submission number |
What descends from it? (15)
See all 152 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K031207 (Casey Surgical, LLC, 2003) has gone furthest, with 14 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 | — |
What is it indicated for?
Synthes Quick Lock™ IMF System is indicated for use in
intermaxillary and maxillo-mandibular fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991004: Synthes Quick Lock Imf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991004
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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