510(k) · Cleared
ClearedPrebent Plating with Virtual Surgical Planning
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation · JEY Plate, Bone
Cleared on Aug 8, 2013 as substantially equivalent to K063052 (Walter Lorenz Surgical, Inc., 2007) and 2 other predicates after a 62-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Aug 8, 2013
- Review
- 62 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K042434 (2004). 9 ancestors in all, the oldest K980512 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK042434 Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
- 4 generations backK043408 Piezosurgery DevicePiezosurgery S.R.L. · 2005
- 3 generations backK060274 PiezotomeSatelec · 2006
- 2 generations backK072146 Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A · 2007
- 1 generation backK113152 Ultrasonic Surgery MachineDmetec.Co., Ltd. · 2012
- This deviceK131674 Prebent Plating with Virtual Surgical PlanningBiomet Microfixation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 | Nouvag AG | 2004 | — |
| −4 | K043408 | Piezosurgery Device | Piezosurgery S.R.L. | 2005 | — |
| −3 | K060274 | Piezotome | Satelec | 2006 | — |
| −2 | K072146 | Ems Piezon Master Surgery | E.M.S Electro Medical Systems S.A | 2007 | — |
| −1 | K113152 | Ultrasonic Surgery Machine | Dmetec.Co., Ltd. | 2012 | — |
| 0 (this device) | K131674 | Prebent Plating with Virtual Surgical Planning | Biomet Microfixation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesSummary page 1…e: 76 JEY (21 CFR 872.4760) AG0821 Secondary Device 76 DZJ Product Code(s): 90 LLZ Predicate Device: K063052- Lorenz Titanium Fracture! Reconstruction Devices and Pre-Bent Plates… | 2007 |
| * | K113152 | Ultrasonic Surgery Machine | 2012 |
| * | K081067 | Fracture/Reconstruction System (Traumaone)Summary page 1…13512- Biomet Microfixation Mandibular Fracture! Reconstruction Devices and Pre-Bent Plates System K08 1067- Fracture/Reconstruction System (TraumaOne) Device Description: The Biomet Microtixation PreBent Plates with Virtual Surgical Pl… | 2008 |
| † | K120956 | VSP System | 2012 |
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 9 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K063052.
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?
For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131674: Prebent Plating with Virtual Surgical Planning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131674
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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