510(k) · Cleared
ClearedOmniPore DUROMAX Surgical Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matrix Surgical Holdings, LLC/Matrix Surgical USA · JEY Plate, Bone
Cleared on Oct 11, 2018 as substantially equivalent to K031761 (Synthes (Usa), 2003) after a 255-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 11, 2018
- Review
- 255 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031761 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031761 Synthes (Usa) New/Sterial Orbital PlatesSynthes (Usa) · 2003
- This deviceK180249 OmniPore DUROMAX Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031761 | Synthes (Usa) New/Sterial Orbital Plates | Synthes (Usa) | 2003 | — |
| 0 (this device) | K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2018 | — |
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 |
|---|---|---|---|
| * | K031761 | Synthes (Usa) New/Sterial Orbital PlatesSummary page 4…4760 Class: II Product Code: JEY Legally Marketed Predicate Devices: Predicate: Synthes USA New Sterile Orbital Plates - 510(k) # K031761 Reference: OmniPore® Surgical Implants - 510(k) # K123908 Synthes [SynPOR] Porous Polyethylene Implants - 510(k) #… | 2003 |
| † | K123908 | Omnipore Surgical Implants and Accessories | 2013 |
| † | K051879 | Synthes (Usa) Porous Polyethylene Implants | 2005 |
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?
- Its one ancestor has no 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. 2018, 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?
OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180249: OmniPore DUROMAX Surgical Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180249
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