510(k) · Cleared
ClearedUniversal Neuro 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 Sep 10, 2003 as substantially equivalent to K022185 (Stryker Instruments, 2002) and 3 other predicates after a 105-day review. Its family tree reaches back 5 generations to 1976. 12 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K761228 (1976). 26 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 4 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 3 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 2 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 1 generation backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- This deviceK031659 Universal Neuro SystemStryker Instruments · 2003
- Descendant · cites it directly · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · 2 generations on · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
- Descendant · 3 generations on · 2 of its ownK140309 CranioplugOssdsign AB · 2014
- Descendant · 4 generations on · 1 of its ownK181539 OSSDSIGN CranioplugOssdsign AB · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K112557Stryker Universal Neuro 3 SystemStryker · 2012 · cites it directly9descendants
- K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · 2 generations on4descendants
- K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker · 2015 · 2 generations on2descendants
- K140309CranioplugOssdsign AB · 2014 · 3 generations on2descendants
- K181539OSSDSIGN CranioplugOssdsign AB · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −4 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −1 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| 0 (this device) | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| +1 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +2 | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | 18 |
| +2 | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver… | Stryker | 2015 | — |
| +3 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +4 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (4)
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 System | 2002 |
| * | K924138 | Osteomed M3 System (SBF System)Summary page 1…Substantial Equivalency Infoimation ‘I’hc StrykerO Leibinger Universal Neuro System is substantially equivalent to legally marketed KO22 185 Universal CMF System, K924 138 Osteomed M 3 System, KO23260 Osteomed 1.2 m m Autodrive Screw System, and KO220 12 Synthes Low Profile Neuro Sy st ei n .… | 1993 |
| * | K023260 | 1.2MM Osteomed Auto-Drive Screw System | 2002 |
| * | K022012 | Synthes Low Profile Neuro System | 2002 |
What descends from it? (12)
See all 123 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 27 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K112557 (Stryker, 2012) has gone furthest, with 9 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.
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 Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031659: Universal Neuro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031659
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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