510(k) · Cleared
ClearedMRI Universal
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 Jul 12, 2024 as substantially equivalent to K221855 (Stryker Leibinger GmbH & Co KG, 2022) after a 127-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 12, 2024
- Review
- 127 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954385 (1996). 12 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 4 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 3 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 2 generations backK022185 Universal CMF SystemStryker Instruments · 2002
- 1 generation backK221855 Universal CMF SystemStryker Leibinger GmbH & Co KG · 2022
- This deviceK240651 MRI UniversalStryker Leibinger GmbH & Co KG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −4 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −3 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −2 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| −1 | K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K221855 | Universal CMF SystemSummary page 8…[§807.92(a)(3)] A. Predicate Devices: The predicate devices for this Bundled, Traditional 510(k) are: 1. Primary Predicate: Universal CMF System – K221855 i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hos… | 2022 |
| † | K171364 | MP LeFort I Plates | 2017 |
| † | K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | 2017 |
| † | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | 2023 |
| † | K133461 | Stryker Universal Orbital Floor System | 2014 |
| † | K980364 | Howmedica and Howmedica Leibinger Bone Screw Washers | 1998 |
| † | K122313 | Stryker Universal Smartlock Hybrid MMF System | 2012 |
| † | K050535 | Stryker MMF Screw | 2005 |
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 28 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 12 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. 2024, 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 Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular…
Read the full statement (524 words)
The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton.
The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
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.
The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton.
The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton.
The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
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.
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240651: MRI Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240651
Report an extraction error
Are you the manufacturer?
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