510(k) · Cleared
ClearedBiomet Microfixation OmniMax MMF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation · JEY Plate, Bone
Cleared on Dec 10, 2015 as substantially equivalent to K143336 (Biomet Microfixation, 2015) after a 114-day review. Its family tree reaches back 6 generations to 1982. 1 later device descends from it.
- Decided
- Dec 10, 2015
- Review
- 114 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K820944 (1982). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 5 generations backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- 4 generations backK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- 3 generations backK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- 2 generations backK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- 1 generation backK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- This deviceK152326 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · cites it directly · 0 of its ownK202969 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2021
Most influential descendants
Showing 1 of 1 · See all- K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −5 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| −4 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| −3 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| −2 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| −1 | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| 0 (this device) | K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +1 | K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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 JEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K143336 | Biomet Microfixation OmniMax MMF SystemSummary page 5…cially Pure Titanium; the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and wires (if used) are manufactured from Stainless Steel. Predicate Devices: K143336, Biomet Microfixation OmniMax MMF System Similarities to Predicate Devices: The predicate and subject devices are metallic impla… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202969 | Biomet Microfixation OmniMax MMF System | 2021 | 0 |
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 33 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K202969 (Biomet Microfixation, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143336.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152326: Biomet Microfixation OmniMax MMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152326
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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