510(k) · Cleared
ClearedLeibinger - Luhr Small Mandibular Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Leibinger, Inc. · JEY Plate, Bone
Cleared on Oct 28, 1996 after a 41-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 167 later devices descend from it.
- Decided
- Oct 28, 1996
- Review
- 41 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
167 later devices descend from it, 2 citing it directly.
- This deviceK963740 Leibinger - Luhr Small Mandibular Bone ScrewsHowmedica Leibinger, Inc. · 1996
- Descendant · cites it directly · 143 of its ownK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 141 of its ownK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- Descendant · 3 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- Descendant · 4 generations on · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- Descendant · 5 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · See all- K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997 · cites it directly143descendants
- K974785Auto-Drive Bone ScrewOsteomed Corp. · 1998 · 2 generations on141descendants
- K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 3 generations on117descendants
- K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · 4 generations on101descendants
- K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 5 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963740 | Leibinger - Luhr Small Mandibular Bone Screws | Howmedica Leibinger, Inc. | 1996 | — |
| +1 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| +3 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| +4 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| +5 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 12 | 0 |
| 2016 | 8 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 11 | 0 |
| 2024 | 18 | 0 |
| 2025 | 17 | 0 |
| 2026 | 16 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (167)
See all 1672 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, K970912 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 143 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/K963740 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963740: Leibinger - Luhr Small Mandibular Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963740
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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