510(k) · Cleared
ClearedKLS-Martin 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 Dec 21, 1999 as substantially equivalent to K963030 (Howmedica Leibinger, Inc., 1997) after a 662-day review. Its family tree reaches back 2 generations to 1982. 8 later devices descend from it.
- Decided
- Dec 21, 1999
- Review
- 662 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. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 1 generation backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- This deviceK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999
- Descendant · cites it directly · 4 of its ownK042573 KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2004
- Descendant · 2 generations on · 3 of its ownK083432 Drill Free MMF ScrewKLS Martin L.P. · 2009
- Descendant · 2 generations on · 1 of its ownK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
- Descendant · cites it directly · 1 of its ownK051871 Stoma Bone ScrewStorz AM Mark GmbH · 2005
- Descendant · 3 generations on · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K042573KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2004 · cites it directly4descendants
- K083432Drill Free MMF ScrewKLS Martin L.P. · 2009 · 2 generations on3descendants
- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024 · 2 generations on1descendant
- K051871Stoma Bone ScrewStorz AM Mark GmbH · 2005 · cites it directly1descendant
- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · 3 generations on0descendants
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) | K980760 | KLS-Martin MMF Screw | KLS-Martin L.P. | 1999 | — |
| +1 | K042573 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2004 | — |
| +2 | K083432 | Drill Free MMF Screw | KLS Martin L.P. | 2009 | — |
| +2 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
| +1 | K051871 | Stoma Bone Screw | Storz AM Mark GmbH | 2005 | — |
| +3 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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…la Lane New Port Richey, FL 34655 AN Phone: 848-376-4154 Fax: &9—376-71 86 41 Ed Ransom February 25, 1998 KLS-Martin MMF Screw Screw, Fixation Leibinger IMF Screw: K963030 The KLS-Martin MMF Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes… | 1997 |
What descends from it? (8)
3 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 17 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, K042573 (KLS-Martin L.P., 2004) has gone furthest, with 4 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 KLS-Martin MMF Screw is intended for use in maxillomandibular fixation to provide
stabilization of fractures of the maxilla, mandible, or both.
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/K980760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980760: KLS-Martin 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/K980760
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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