510(k) · Cleared
ClearedKLS-Martin Mandibular Fracture/Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Leibinger GmbH U. Co. KG · JEY Plate, Bone
Cleared on Mar 23, 1995 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 438 later devices descend from it.
- Decided
- Mar 23, 1995
- Review
- 77 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
438 later devices descend from it, 2 citing it directly.
- This deviceK950045 KLS-Martin Mandibular Fracture/Reconstruction SystemKarl Leibinger GmbH U. Co. KG · 1995
- Descendant · cites it directly · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- Descendant · 2 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · 3 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · 4 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
Showing 5 of 438 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 438 · See all- K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · cites it directly435descendants
- K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 2 generations on360descendants
- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 3 generations on343descendants
- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 4 generations on342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 5 generations on339descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950045 | KLS-Martin Mandibular Fracture/Reconstruction System | Karl Leibinger GmbH U. Co. KG | 1995 | — |
| +1 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| +2 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +3 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| +5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 15 | 0 |
| 2013 | 9 | 0 |
| 2014 | 18 | 0 |
| 2015 | 26 | 0 |
| 2016 | 16 | 0 |
| 2017 | 32 | 0 |
| 2018 | 17 | 0 |
| 2019 | 21 | 0 |
| 2020 | 28 | 0 |
| 2021 | 28 | 0 |
| 2022 | 29 | 0 |
| 2023 | 38 | 0 |
| 2024 | 54 | 0 |
| 2025 | 39 | 0 |
| 2026 | 51 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (438)
See all 4382 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?
- Of its descendants, K032442 (KLS-Martin L.P., 2003) has gone furthest, with 435 descendants of its own.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
https://510kreport.com/device/K950045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950045: KLS-Martin Mandibular Fracture/Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950045
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026