510(k) · Cleared
ClearedMedpor Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · JEY Plate, Bone
Cleared on Jun 28, 2010 as substantially equivalent to K021642 (Synthes (Usa), 2002) and 2 other predicates after a 375-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jun 28, 2010
- Review
- 375 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954385 (1996). 13 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 3 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 2 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 1 generation backK022185 Universal CMF SystemStryker Instruments · 2002
- This deviceK091807 Medpor Fixation SystemPorex Surgical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −3 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −2 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −1 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| 0 (this device) | K091807 | Medpor Fixation System | Porex Surgical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K021642 | Synthes Craniofacial PlatesSummary page 1….4880 - Screw, Fixation, Intraosseous Product Code: JEY Subsequent Product Code: DZL Substantially equivalent to: 1) Synthes (USA) Synthes Craniofacial Plates K02 1642 2) Synthes (USA) SMF Ti Alloy Bone Screws K963546 3) Stryker Leibenger Universal CMF System K022185… | 2002 |
| * | K963546 | SMF Titanium (TI) Alloy Bone ScrewsSummary page 1…bsequent Product Code: DZL Substantially equivalent to: 1) Synthes (USA) Synthes Craniofacial Plates K02 1642 2) Synthes (USA) SMF Ti Alloy Bone Screws K963546 3) Stryker Leibenger Universal CMF System K022185 5 -I POREX… | 1997 |
| * | K022185 | Universal CMF SystemSummary page 1…1) Synthes (USA) Synthes Craniofacial Plates K02 1642 2) Synthes (USA) SMF Ti Alloy Bone Screws K963546 3) Stryker Leibenger Universal CMF System K022185 5 -I POREX SURGICAL PRODUCTS GROUP Device Description: The Porex… | 2002 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 3 other devices also cite its predicate K021642.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Porex Fixation System for maxillofacial surgery is intended for
rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction.
The Porex Fixation System For Maxillofacial Surgery is intended for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091807: Medpor Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091807
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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