510(k) · Cleared
ClearedStryker MEDPOR TITAN 3D Orbital Floor Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on May 5, 2015 as substantially equivalent to K133461 (Stryker, 2014) after a 235-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- May 5, 2015
- Review
- 235 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K080331 (2008). No later device cites it as a predicate yet.
- Root · 3 generations backK080331 Synthes Craniofacial Plate and Screw SystemSynthes (Usa) · 2008
- 2 generations backK123786 Stryker Universal Orbital Floor SystemStryker · 2013
- 1 generation backK133461 Stryker Universal Orbital Floor SystemStryker · 2014
- This deviceK142568 Stryker MEDPOR TITAN 3D Orbital Floor ImplantStryker · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K080331 | Synthes Craniofacial Plate and Screw System | Synthes (Usa) | 2008 | — |
| −2 | K123786 | Stryker Universal Orbital Floor System | Stryker | 2013 | — |
| −1 | K133461 | Stryker Universal Orbital Floor System | Stryker | 2014 | — |
| 0 (this device) | K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker | 2015 | — |
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 |
|---|---|---|---|
| * | K133461 | Stryker Universal Orbital Floor SystemSummary page 4…ate (21 CFR 872.4760) name: Regulatory Class: Class II Product Code: JEY III. PREDICATE DEVICE Predicate Device: Stryker Universal Orbital Floor System – K133461 Reference Device: MEDPOR Craniofacial Implants with Embedded Titanium Mesh – K040364 Traditional 510(k)… | 2014 |
| † | K040364 | Medpor Craniofacial Implants with Embedded Titanium Mesh | 2004 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 MEDPOR TITAN® 3D Orbital Floor Implant 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/K142568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142568: Stryker MEDPOR TITAN 3D Orbital Floor Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142568
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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