510(k) · Cleared
ClearedKLS Martin Drill-Free MMF Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · DZL Screw, Fixation, Intraosseous
Cleared on Sep 17, 2024 as substantially equivalent to K083432 (KLS Martin L.P., 2009) after a 301-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Sep 17, 2024
- Review
- 301 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820944 (1982). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 4 generations backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- 3 generations backK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999
- 2 generations backK042573 KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2004
- 1 generation backK083432 Drill Free MMF ScrewKLS Martin L.P. · 2009
- This deviceK233721 KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2024
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 | K963030 | Leibinger Imf Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K980760 | KLS-Martin MMF Screw | KLS-Martin L.P. | 1999 | — |
| −2 | K042573 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2004 | — |
| −1 | K083432 | Drill Free MMF Screw | KLS Martin L.P. | 2009 | — |
| 0 (this device) | K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K083432 | Drill Free MMF ScrewSummary page 5…ber 872.4880 Product Code DZL I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K083432 Drill Free MMF Screw DZL K231599 Stryker MMF Screw DZL K153482 KLS Martin Thoracic Plating System HRS Device Description Summary… | 2009 |
| * | — | Stryker MMF Screw Named without a submission number | |
| * | — | KLS Martin Thoracic Plating System Named without a submission number | |
| † | K153482 | KLS Martin Thoracic Plating System | 2016 |
| † | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | 2023 |
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 42 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 17 ancestors has a recall.
- 1 other device also cites its predicate K083432.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The KLS Martin Drill-Free MMF Screw is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233721: KLS Martin Drill-Free MMF Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233721
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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