510(k) · Cleared
ClearedStryker Universal Smartlock Hybrid MMF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Oct 31, 2012 as substantially equivalent to K050535 (Stryker Instruments, 2005) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 1982. 10 later devices descend from it.
- Decided
- Oct 31, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820944 (1982). 10 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 3 generations backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- 2 generations backK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- 1 generation backK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- This deviceK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- Descendant · cites it directly · 5 of its ownK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · cites it directly · 4 of its ownK141165 Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014
- 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 · 2 generations on · 1 of its ownK152326 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015 · cites it directly5descendants
- K141165Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014 · cites it directly4descendants
- 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 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −3 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| −2 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| −1 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| 0 (this device) | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| +1 | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +1 | K141165 | Matrixwave MMF System | Synthes (USA) Products, LLC | 2014 | — |
| +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 | — |
| +2 | K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K050535 | Stryker MMF ScrewSummary page 1…DZL - lntraosseous fixation screw or wire JEY - Bone Plate Predicate Device: Stryker MM F Screw - K050535 KLS Martin Erich Arch Bar - K061 271 Intended Use: The Stryker Universal SMARTI-ock… | 2005 |
| * | K061271 | Erch Arch Bar, Model 38-690-00Summary page 1…JEY - Bone Plate Predicate Device: Stryker MM F Screw - K050535 KLS Martin Erich Arch Bar - K061 271 Intended Use: The Stryker Universal SMARTI-ock Hybrid MMF System is intended to be used for temporary stabilization of mandibula… | 2006 |
What descends from it? (10)
5 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 30 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K143336 (Biomet Microfixation, 2015) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122313: Stryker Universal Smartlock Hybrid 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/K122313
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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