510(k) · Cleared
ClearedStryker Universal Orbital Floor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Aug 1, 2014 as substantially equivalent to K123786 (Stryker, 2013) after a 262-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Aug 1, 2014
- Review
- 262 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080331 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK080331 Synthes Craniofacial Plate and Screw SystemSynthes (Usa) · 2008
- 1 generation backK123786 Stryker Universal Orbital Floor SystemStryker · 2013
- This deviceK133461 Stryker Universal Orbital Floor SystemStryker · 2014
- Descendant · cites it directly · 0 of its ownK142568 Stryker MEDPOR TITAN 3D Orbital Floor ImplantStryker · 2015
Most influential descendants
Showing 1 of 1 · See all- K142568Stryker MEDPOR TITAN 3D Orbital Floor ImplantStryker · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K080331 | Synthes Craniofacial Plate and Screw System | Synthes (Usa) | 2008 | — |
| −1 | K123786 | Stryker Universal Orbital Floor System | Stryker | 2013 | — |
| 0 (this device) | K133461 | Stryker Universal Orbital Floor System | Stryker | 2014 | — |
| +1 | K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K123786 | Stryker Universal Orbital Floor SystemSummary page 5…egulation Number: 872.4760 Bone Plate Product Codes: JEY Predicate Device: Stryker Universal Orbital Floor System, K123786 Introduction: This Traditional 510(k) is being submitted to the FDA to grant clearance to market the Stryker Universal Orbital… | 2013 |
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 |
|---|---|---|---|
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | 2015 | 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?
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133461: Stryker Universal Orbital Floor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133461
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