510(k) · Cleared
ClearedStryker MP, Mandible, HMMF and MMF AXS Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · DZL Screw, Fixation, Intraosseous
Cleared on Aug 24, 2023 as substantially equivalent to K122313 (Stryker, 2012) after an 84-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Aug 24, 2023
- Review
- 84 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820944 (1982). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK231599 Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co KG · 2023
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) | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | 2023 | — |
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 |
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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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 |
|---|---|---|---|
| * | K122313 | Stryker Universal Smartlock Hybrid MMF SystemSummary page 5…es: The Predicate/Reference Devices for this Bundled, Traditional 510(k) are: 1. Primary Predicate Device: Stryker SMARTLock Hybrid MMF System - K122313 i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hos… | 2012 |
| † | K221855 | Universal CMF System | 2022 |
| † | K050535 | Stryker MMF Screw | 2005 |
| † | K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | 2017 |
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?
- The line of descent spans 41 years and passes through 6 companies; a new generation was cleared every 6.3 years on median.
- None of the 11 ancestors has a recall.
- 4 other devices also cite its predicate K122313.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
-Stryker Universal SMARTLock Hybrid MMF System: The Stryker Universal SMARTLock Hybrid MME 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. -Universal CMF System: Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and…
Read the full statement (129 words)
-Stryker Universal SMARTLock Hybrid MMF System:
The Stryker Universal SMARTLock Hybrid MME 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.
-Universal CMF System:
Craniomaxillofacial Implants
The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization,
and rigid fixation of CMF fractures and reconstruction.
Mandible Implants
The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and
rigid fixation of mandibular fractures and mandibular reconstruction.
-Stryker MMF screw:
The Stryker MME Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide
indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231599: Stryker MP, Mandible, HMMF and MMF AXS Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231599
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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