510(k) · Cleared
ClearedSafety Release Arch Bar Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Casey Surgical, LLC · DYX Lock, Wire, And Ligature, Intraoral
Cleared on Jul 15, 2003 as substantially equivalent to K991004 (Synthes (Usa), 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1982. 14 later devices descend from it.
- Decided
- Jul 15, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- DYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K820944 (1982). 3 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 1 generation backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- This deviceK031207 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
- 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 |
|---|---|---|---|---|---|
| −2 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −1 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| 0 (this device) | 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 | — |
| +3 | K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018 | — |
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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K991004 | Synthes Quick Lock Imf SystemSummary page 1…TM Arch Bar Kit Common Name: Intermaxillary Fixation System Classification Name: Intraoral ligature and wire lock Predicate Devices: Synthes Quick LockTM K99 1004 Unisplint KS20944 Device Description: The Casey Surgical Safety Release TM Arch Bar Kit is made of four c… | 1999 |
| * | K820944 | Dental Arch Bar | 1982 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061271 | Erch Arch Bar, Model 38-690-00 | 2006 | 13 |
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 17.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K061271 (KLS-Martin L.P., 2006) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K991004.
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?
Casey Surgical Safety Release TM Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031207: Safety Release Arch Bar Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031207
Report an extraction error
Are you the manufacturer?
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