510(k) · Cleared
ClearedDrill 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 Mar 31, 2009 as substantially equivalent to K042573 (KLS-Martin L.P., 2004) and 1 other predicate after a 131-day review. Its family tree reaches back 4 generations to 1982. 3 later devices descend from it.
- Decided
- Mar 31, 2009
- Review
- 131 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820944 (1982). 16 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 3 generations backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- 2 generations backK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999
- 1 generation backK042573 KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2004
- This deviceK083432 Drill Free MMF ScrewKLS Martin L.P. · 2009
- Descendant · cites it directly · 1 of its ownK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
- Descendant · 2 generations on · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
- Descendant · cites it directly · 0 of its ownK233721 KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2024
Most influential descendants
Showing 3 of 3 · See all- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024 · cites it directly1descendant
- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · 2 generations on0descendants
- K233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2024 · cites it directly0descendants
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 | K963030 | Leibinger Imf Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K980760 | KLS-Martin MMF Screw | KLS-Martin L.P. | 1999 | — |
| −1 | K042573 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2004 | — |
| 0 (this device) | K083432 | Drill Free MMF Screw | KLS Martin L.P. | 2009 | — |
| +1 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
| +2 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K042573 | KLS Martin Drill-Free MMF ScrewSummary page 1…raosseous fixation screw or wire Name and Number: (CFR 872.4880) Regulatory Class: Class II Predicate Devices: KLS Martin Drill Free MMF Screw (K042573) IMF Screws (K010527) Intended Use: The Drill Free MMF Screw is intended for use… | 2004 |
| * | K010527 | Synthes (Usa) Imf ScrewsSummary page 1…r: (CFR 872.4880) Regulatory Class: Class II Predicate Devices: KLS Martin Drill Free MMF Screw (K042573) IMF Screws (K010527) Intended Use: The Drill Free MMF Screw is intended for use in maxillomandibular fixation… | 2001 |
What descends from it? (3)
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 27 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K241314 (KLS-Martin L.P., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K042573.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083432: Drill Free MMF Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083432
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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