510(k) · Cleared
ClearedMicro Dynamic Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JEY Plate, Bone
Cleared on Dec 23, 1998 after a 76-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Dec 23, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK983528 Micro Dynamic MeshHowmedica Corp. · 1998
- Descendant · cites it directly · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · 2 generations on · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
- Descendant · cites it directly · 3 of its ownK113109 Stryker Resorbable Fixation SystemStryker · 2011
- Descendant · 2 generations on · 2 of its ownK213777 Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants · 2022
- Descendant · 2 generations on · 2 of its ownK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112557Stryker Universal Neuro 3 SystemStryker · 2012 · cites it directly9descendants
- K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · 2 generations on4descendants
- K113109Stryker Resorbable Fixation SystemStryker · 2011 · cites it directly3descendants
- K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants · 2022 · 2 generations on2descendants
- K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983528 | Micro Dynamic Mesh | Howmedica Corp. | 1998 | — |
| +1 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +2 | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | 18 |
| +1 | K113109 | Stryker Resorbable Fixation System | Stryker | 2011 | — |
| +2 | K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022 | — |
| +2 | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver… | Stryker | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | TiMesh™ System (TiMesh Inc. & Sofamor Danek USA) Named without a submission number | |
| * | — | 1.5/2.0 Combination Titanium Osteosynthesis System (Walter Lorenz) Named without a submission number | |
| * | — | Osteomed’s TRAM™ Named without a submission number |
What descends from it? (13)
See all 132 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, K112557 (Stryker, 2012) has gone furthest, with 9 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 | — |
What is it indicated for?
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity (including the mandible and maxilla).
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/K983528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983528: Micro Dynamic Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983528
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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