510(k) · Cleared
ClearedUniversal CMF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · JEY Plate, Bone
Cleared on Nov 9, 2022 as substantially equivalent to K022185 (Stryker Instruments, 2002) and 1 other predicate after a 135-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Nov 9, 2022
- Review
- 135 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954385 (1996). 11 ancestors in all, the oldest K854886 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 3 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 2 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 1 generation backK022185 Universal CMF SystemStryker Instruments · 2002
- This deviceK221855 Universal CMF SystemStryker Leibinger GmbH & Co KG · 2022
- Descendant · cites it directly · 0 of its ownK240651 MRI UniversalStryker Leibinger GmbH & Co KG · 2024
Most influential descendants
Showing 1 of 1 · See all- K240651MRI UniversalStryker Leibinger GmbH & Co KG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −3 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −2 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −1 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| 0 (this device) | K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| +1 | K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K022185 | Universal CMF SystemSummary page 5…2(a)(3)] A. Predicate Devices: The predicate devices for this bundled, traditional 510(k) are: 1. Universal CMF System - K022185 i. Submission Branch of Predicate Device- Division of Anesthesiology,… | 2002 |
| * | K014263 | Newgen/Universal Mandibular SystemSummary page 5…Device Evaluation, Center for Devices and Radiological Health 2. Stryker NewGen/Universal Mandibular System - K014263 i. Submission Branch of Predicate Device- Division of Dental, Infection… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240651 | MRI Universal | 2024 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K240651 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K022185.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Craniomaxillofacial Implants:
The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.
Mandible Implants:
The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221855: Universal CMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221855
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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