510(k) · Cleared
ClearedUniversal CMF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · JEY Plate, Bone
Cleared on Dec 17, 2002 as substantially equivalent to K014263 (Stryker Instruments, 2002) and 6 other predicates after a 167-day review. Its family tree reaches back 3 generations to 1996. 33 later devices descend from it.
- Decided
- Dec 17, 2002
- Review
- 167 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K954385 (1996). 10 ancestors in all, the oldest K854886 (1986). 33 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 2 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 1 generation backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- This deviceK022185 Universal CMF SystemStryker Instruments · 2002
- Descendant · cites it directly · 12 of its ownK031659 Universal Neuro SystemStryker Instruments · 2003
- Descendant · 2 generations on · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · 3 generations on · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK041651 Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
- Descendant · cites it directly · 2 of its ownK161821 Stryker Universal MeshStryker · 2016
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K031659Universal Neuro SystemStryker Instruments · 2003 · cites it directly12descendants
- K112557Stryker Universal Neuro 3 SystemStryker · 2012 · 2 generations on9descendants
- K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · 3 generations on4descendants
- K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004 · cites it directly4descendants
- K161821Stryker Universal MeshStryker · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −2 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −1 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| 0 (this device) | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| +1 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| +2 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +3 | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | 18 |
| +1 | K041651 | Stryker Leibinger Skeletal Anchoring System | Stryker Leibinger | 2004 | — |
| +1 | K161821 | Stryker Universal Mesh | Stryker | 2016 | — |
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 |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (7)
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 System | 2002 |
| * | K002619 | Newgen System | 2000 |
| * | K862482 | Steinhauser Titanium Mini Bone Plates & ScrewsSummary page 1…The StrykeB Leibinger Universal CMF System is substantially equivalent to legally marketed KO14263 NewGen Mandibular System, KO02619 NewGen System , K862482 Steinhauser Titanium Mini Bone Plates & Screws, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthe… | 1986 |
| * | K854886 | Wuerzburg Titanium Mini Bone Plates & Bone ScrewsSummary page 1…stantially equivalent to legally marketed KO14263 NewGen Mandibular System, KO02619 NewGen System , K862482 Steinhauser Titanium Mini Bone Plates & Screws, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthes Midfacial System, K993862 MODUSB Titanium Osteo… | 1986 |
| * | K953806 | Synthes (Usa) Midfacial SystemSummary page 1…dibular System, KO02619 NewGen System , K862482 Steinhauser Titanium Mini Bone Plates & Screws, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthes Midfacial System, K993862 MODUSB Titanium Osteosynthesis System and K862532 Dumbach Titanium Mesh Lmplant S… | 1996 |
| * | K993862 | Modus Sagittal Split PlateSummary page 1…tem , K862482 Steinhauser Titanium Mini Bone Plates & Screws, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthes Midfacial System, K993862 MODUSB Titanium Osteosynthesis System and K862532 Dumbach Titanium Mesh Lmplant System. Wade T. Rutkoslue Regulatory Aff… | 1999 |
| * | K862532 | Dumbach Titanium Mesh Implant SystemSummary page 1…ews, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthes Midfacial System, K993862 MODUSB Titanium Osteosynthesis System and K862532 Dumbach Titanium Mesh Lmplant System. Wade T. Rutkoslue Regulatory Affairs Associate DEPARTMENT OE I1EALTI-I h… | 1986 |
What descends from it? (33)
See all 3312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031659 | Universal Neuro System | 2003 | 12 |
| K041651 | Stryker Leibinger Skeletal Anchoring System | 2004 | 4 |
| K161821 | Stryker Universal Mesh | 2016 | 2 |
| K080694 | Osteomed Modular Locking Fixation System | 2008 | 2 |
| K221855 | Universal CMF System | 2022 | 1 |
| K170773 | Stryker Universal Mesh | 2017 | 1 |
| K220360 | Tandry CMF Plate System | 2022 | 0 |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | 2017 | 0 |
| K171364 | MP LeFort I Plates | 2017 | 0 |
| K091807 | Medpor Fixation System | 2010 | 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 6 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K031659 (Stryker Instruments, 2003) has gone furthest, with 12 descendants 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.
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 Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022185: Universal CMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022185
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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