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 Apr 1, 2015 as substantially equivalent to K061271 (KLS-Martin L.P., 2006) and 2 other predicates after a 132-day review. Its family tree reaches back 5 generations to 1982. 5 later devices descend from it.
- Decided
- Apr 1, 2015
- Review
- 132 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K820944 (1982). 13 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 4 generations backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- 3 generations backK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- 2 generations backK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- 1 generation backK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- This deviceK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · cites it directly · 2 of its ownK173320 KLS Martin L1 MMF SystemKLS Martin L.P. · 2018
- Descendant · 2 generations on · 1 of its ownK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
- Descendant · cites it directly · 1 of its ownK152326 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · 3 generations on · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
- Descendant · 2 generations on · 0 of its ownK202969 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2021
Most influential descendants
Showing 5 of 5 · See all- K173320KLS Martin L1 MMF SystemKLS Martin L.P. · 2018 · cites it directly2descendants
- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024 · 2 generations on1descendant
- K152326Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015 · cites it directly1descendant
- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · 3 generations on0descendants
- K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −4 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| −3 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| −2 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| −1 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| 0 (this device) | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +1 | K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018 | — |
| +2 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
| +1 | K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +3 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K061271 | Erch Arch Bar, Model 38-690-00Summary page 5…= Page 5 === plate is manufactured from Commercially Pure Titanium; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V). Predicate Devices: Primary: K061271, KLS Erich Arch Bar Secondary: K122313, Stryker Universal SMARTLock Hybrid MMF System K040983, Lorenz Self-Drilling IMF Screw Si… | 2006 |
| * | K122313 | Stryker Universal Smartlock Hybrid MMF SystemSummary page 5…Commercially Pure Titanium; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V). Predicate Devices: Primary: K061271, KLS Erich Arch Bar Secondary: K122313, Stryker Universal SMARTLock Hybrid MMF System K040983, Lorenz Self-Drilling IMF Screw Similarities to Predicate Devices: The pr… | 2012 |
| * | K040983 | Lorenz Self-Drilling Imf ScrewSummary page 5…manufactured from Titanium Alloy (Ti-6Al-4V). Predicate Devices: Primary: K061271, KLS Erich Arch Bar Secondary: K122313, Stryker Universal SMARTLock Hybrid MMF System K040983, Lorenz Self-Drilling IMF Screw Similarities to Predicate Devices: The predicate and subject devices are metallic implants inten… | 2004 |
What descends from it? (5)
2 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?
- 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 13 ancestors has a recall.
- Of its descendants, K173320 (KLS Martin L.P., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K061271.
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/K143336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143336: Biomet Microfixation OmniMax MMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143336
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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