510(k) · Cleared
ClearedPaulus Titanium Mini Bone Plates & Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · JEY Plate, Bone
Cleared on Aug 7, 1986 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Aug 7, 1986
- Review
- 36 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK862534 Paulus Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986
- Descendant · cites it directly · 5 of its ownK121589 Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK140037 Optimus CMF SystemOsteonic Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK253373 Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK182609 Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019
- Descendant · 3 generations on · 0 of its ownK160363 Optimus CMF SystemOsteonic Co., Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012 · cites it directly5descendants
- K140037Optimus CMF SystemOsteonic Co., Ltd. · 2015 · 2 generations on2descendants
- K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025 · 3 generations on0descendants
- K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019 · 2 generations on0descendants
- K160363Optimus CMF SystemOsteonic Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862534 | Paulus Titanium Mini Bone Plates & Bone Screws | Walter Lorenz Surgical, Inc. | 1986 | — |
| +1 | K121589 | Biomet Microfixation Facial Plating System | Biomet Microfixation | 2012 | 1 |
| +2 | K140037 | Optimus CMF System | Osteonic Co., Ltd. | 2015 | — |
| +3 | K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty), Ltd. | 2025 | — |
| +2 | K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019 | — |
| +3 | K160363 | Optimus CMF System | Osteonic Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 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? (7)
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?
- Of its descendants, K121589 (Biomet Microfixation, 2012) has gone furthest, with 5 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/K862534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K862534: Paulus Titanium Mini Bone Plates & Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862534
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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