510(k) · Cleared
ClearedMacroporemx Mandibular Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · JEY Plate, Bone
Cleared on Oct 19, 2000 after a 232-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 19, 2000
- Review
- 232 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK000696 Macroporemx Mandibular Fixation SystemMacropore Biosurgery, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
- Descendant · 3 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002 · cites it directly5descendants
- K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · cites it directly3descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 2 generations on2descendants
- K121606Resorb-X GKLS-Martin L.P. · 2013 · 3 generations on0descendants
- K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000696 | Macroporemx Mandibular Fixation System | Macropore Biosurgery, Inc. | 2000 | — |
| +1 | K011569 | Biosorbfx O/M 2.0/2/4 System | Bionx Implants, Inc. | 2002 | — |
| +1 | K061881 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2007 | — |
| +2 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +3 | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
| +3 | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | Porex Surgical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K011569 (Bionx Implants, Inc., 2002) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K000696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000696: Macroporemx Mandibular 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/K000696
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026