510(k) · Cleared
ClearedDumbach Titanium Mesh Implant System
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 Sep 5, 1986 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.
- Decided
- Sep 5, 1986
- Review
- 65 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 3 citing it directly.
- This deviceK862532 Dumbach Titanium Mesh Implant SystemWalter Lorenz Surgical, Inc. · 1986
- Descendant · cites it directly · 33 of its ownK022185 Universal CMF SystemStryker Instruments · 2002
- Descendant · 2 generations on · 12 of its ownK031659 Universal Neuro SystemStryker Instruments · 2003
- Descendant · 3 generations on · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · cites it directly · 6 of its ownK983360 Macropore Protective SheetPacific Materials and Interfaces · 1999
- Descendant · 2 generations on · 5 of its ownK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K022185Universal CMF SystemStryker Instruments · 2002 · cites it directly33descendants
- K031659Universal Neuro SystemStryker Instruments · 2003 · 2 generations on12descendants
- K112557Stryker Universal Neuro 3 SystemStryker · 2012 · 3 generations on9descendants
- K983360Macropore Protective SheetPacific Materials and Interfaces · 1999 · cites it directly6descendants
- K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862532 | Dumbach Titanium Mesh Implant System | Walter Lorenz Surgical, Inc. | 1986 | — |
| +1 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| +2 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| +3 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +1 | K983360 | Macropore Protective Sheet | Pacific Materials and Interfaces | 1999 | — |
| +2 | K011569 | Biosorbfx O/M 2.0/2/4 System | Bionx Implants, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (43)
See all 433 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, K022185 (Stryker Instruments, 2002) has gone furthest, with 33 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/K862532 · printed Nov 5, 2026
Cite this page
510(k) Report. “K862532: Dumbach Titanium Mesh Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K862532
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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