510(k) · Cleared
ClearedStryker Customized Mandible Recon Plate Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Dec 6, 2013 as substantially equivalent to K014263 (Stryker Instruments, 2002) and 2 other predicates after a 116-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 6, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K904111 (1990). 16 ancestors in all, the oldest K832283 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 4 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 3 generations backK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- 2 generations backK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- 1 generation backK121153 Peek Customized Craial Implant KitStryker · 2012
- This deviceK132519 Stryker Customized Mandible Recon Plate KitStryker · 2013
- Descendant · cites it directly · 1 of its ownK193136 Stryker Customized Mandible Recon Plate KitStryker · 2020
- Descendant · 2 generations on · 0 of its ownK222650 Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible…Stryker Craniomaxillofacial (Cmf) · 2022
- Descendant · cites it directly · 0 of its ownK190696 Stryker Surgeon iD Mandible Recon PlateStryker · 2019
Most influential descendants
Showing 3 of 3 · See all- K193136Stryker Customized Mandible Recon Plate KitStryker · 2020 · cites it directly1descendant
- K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf) · 2022 · 2 generations on0descendants
- K190696Stryker Surgeon iD Mandible Recon PlateStryker · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −4 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −3 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| −2 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| −1 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| 0 (this device) | K132519 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2013 | — |
| +1 | K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2020 | — |
| +2 | K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | 2022 | — |
| +1 | K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K014263 | Newgen/Universal Mandibular SystemSummary page 1…for intended use, indications for use, and technical characteristics are: 1. Stryker NewGen/Universal Mandibular System - K014263 2. Synthes Patient Specific Plates - K1 22647 The predicate device for the patient-… | 2002 |
| * | K122647 | Synthes Patient Specific PlateSummary page 1…echnical characteristics are: 1. Stryker NewGen/Universal Mandibular System - K014263 2. Synthes Patient Specific Plates - K1 22647 The predicate device for the patient-specific ordering, designing, and logistics pr… | 2013 |
| * | K121153 | Peek Customized Craial Implant KitSummary page 1…ce for the patient-specific ordering, designing, and logistics process is: 3. Stryker PEEK Customized Cranial Implant Kit - K121 153 Intended Use: The Customized Mandible Recon Plate Kit is intended to be used for rigid internal f… | 2012 |
What descends from it? (3)
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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K193136 (Stryker, 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K014263.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132519: Stryker Customized Mandible Recon Plate Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132519
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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