510(k) · Cleared
ClearedStryker Facial iD Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 26, 2020 as substantially equivalent to K182305 (Stryker, 2019) after a 134-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Mar 26, 2020
- Review
- 134 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063790 (2007). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK063790 The Synthes Matrixmandible Plate and Screw SystemSynthes (Usa) · 2007
- 2 generations backK170272 TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017 · Recalled
- 1 generation backK182305 Stryker Facial iD Plating SystemStryker · 2019
- This deviceK193143 Stryker Facial iD Plating SystemStryker · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| −2 | K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017 | 2 |
| −1 | K182305 | Stryker Facial iD Plating System | Stryker | 2019 | — |
| 0 (this device) | K193143 | Stryker Facial iD Plating System | Stryker | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K182305 | Stryker Facial iD Plating SystemSummary page 4…Usual name: Classification Bone Plate; 21 CFR §872.4760 name: Regulatory Class: Class II Product Code: JEY IV. PREDICATE DEVICE Primary Predicate: K182305, Stryker Facial iD Plating System Reference Device: K192192, VSP® System Page 1-1… | 2019 |
| † | K192192 | VSP System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
The Stryker Facial iD Plating System is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures
and reconstruction in adults and adolescents (age 12 and higher).
Specific Indications for Use:
-Orthognathic surgery
-Reconstructive maxillofacial surgery
-Mandible and maxillofacial trauma surgery.
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/K193143 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193143: Stryker Facial iD Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193143
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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