510(k) · Cleared
ClearedStryker MMF Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · DZL Screw, Fixation, Intraosseous
Cleared on Mar 17, 2005 as substantially equivalent to K963030 (Howmedica Leibinger, Inc., 1997) after a 15-day review. Its family tree reaches back 2 generations to 1982. 11 later devices descend from it.
- Decided
- Mar 17, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K820944 (1982). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 1 generation backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- This deviceK050535 Stryker MMF ScrewStryker Instruments · 2005
- Descendant · cites it directly · 10 of its ownK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- Descendant · 2 generations on · 5 of its ownK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · 2 generations on · 4 of its ownK141165 Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK173320 KLS Martin L1 MMF SystemKLS Martin L.P. · 2018
- Descendant · 3 generations on · 1 of its ownK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122313Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012 · cites it directly10descendants
- K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015 · 2 generations on5descendants
- K141165Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014 · 2 generations on4descendants
- K173320KLS Martin L1 MMF SystemKLS Martin L.P. · 2018 · 2 generations on2descendants
- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −1 | K963030 | Leibinger Imf Screw | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K050535 | Stryker MMF Screw | Stryker Instruments | 2005 | — |
| +1 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| +2 | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +2 | K141165 | Matrixwave MMF System | Synthes (USA) Products, LLC | 2014 | — |
| +2 | K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018 | — |
| +3 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K963030 | Leibinger Imf ScrewSummary page 1…is sufficient occlusion. Substantial Equivalence EQUIVALENT PRODUCTS: The Stryker® MMF Screw is substantially equivalent to the Leibinger® IMF Screw, K963030 (Howmedica Leibinger). thM.lis-ma Regulatory Affairs Representative Strykerg Instruments Leibinger Micro Implants Divisi… | 1997 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122313 | Stryker Universal Smartlock Hybrid MMF System | 2012 | 10 |
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 23 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122313 (Stryker, 2012) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K963030.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Stryker® MMF Screw is intended for use as a bone screw in temporary maxillomandibular fixation, providing 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/K050535 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050535: Stryker MMF Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050535
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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