510(k) · Cleared
ClearedOsteomed Low Profile Orbital Floor Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Dec 18, 2014 as substantially equivalent to K031761 (Synthes (Usa), 2003) and 1 other predicate after a 246-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Dec 18, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K080331 (2008). 3 ancestors in all, the oldest K031761 (2003). No later device cites it as a predicate yet.
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) | K140978 | Osteomed Low Profile Orbital Floor Plate System | Osteomed | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K031761 | Synthes (Usa) New/Sterial Orbital PlatesSummary page 4…Plate, bone Product Code: JEY- Bone Plate Device Classification: 21 CFR Part §872.4760 — Bone plate Legally Marketed Predicate Devices: Synthes MatrixMIDFACE System (K031761) Stryker Universal Orbital Floor Plate System (K123786) Device Description: The OSTEOMED Low Profile Orbital Floor Plate System… | 2003 |
| * | K123786 | Stryker Universal Orbital Floor SystemSummary page 4…ssification: 21 CFR Part §872.4760 — Bone plate Legally Marketed Predicate Devices: Synthes MatrixMIDFACE System (K031761) Stryker Universal Orbital Floor Plate System (K123786) Device Description: The OSTEOMED Low Profile Orbital Floor Plate System is a permanent implant that is provided non sterile an… | 2013 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K031761.
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 OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140978: Osteomed Low Profile Orbital Floor Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140978
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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