510(k) · Cleared
ClearedMINNE TIES MMF Suture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Medical, Inc. · DYX Lock, Wire, And Ligature, Intraoral
Cleared on Apr 11, 2017 as substantially equivalent to K030605 (Zygomatics, Ltd., 2003) after a 260-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Apr 11, 2017
- Review
- 260 days
- Class
- Class II
- Product code
- DYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030605 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030605 Rapid ImfZygomatics, Ltd. · 2003
- This deviceK162046 MINNE TIES MMF Suture SystemSummit Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030605 | Rapid Imf | Zygomatics, Ltd. | 2003 | — |
| 0 (this device) | K162046 | MINNE TIES MMF Suture System | Summit Medical, Inc. | 2017 | — |
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? (1)
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 |
|---|---|---|---|
| * | K030605 | Rapid ImfSummary page 5…and stainless steel. The cheek retractor is made of polypropylene. Predicate Device Trade/Device Name/510(k) Rapid IMF™ - K030605 Comparison of Subject MINNE TIES™ MMF Predicate Device: Device to Predicate Device… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2017, this device’s year, is highlighted.
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?
The MINNE TIES MMF Suture System is an adjustable flexible plastic band that wraps between and around a tooth to create an anchorage point for maxilla-mandibular fixation and immobilization. MINNE TIES MMF Suture System is suitable for:
- Pre-operative fixation
- Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation
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/K162046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162046: MINNE TIES MMF Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162046
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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