510(k) · Cleared
ClearedMacropore FX, PS, NS, LP
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 Sep 18, 2001 as substantially equivalent to K002207 (Macropore Biosurgery, Inc., 2001) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Sep 18, 2001
- Review
- 50 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900138 (1990). 6 ancestors in all. 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 | K900138 | Motech Titanium Surgical Mesh | Biedermann Motech GmbH | 1990 | — |
| −1 | K972913 | Macropore Protective Sheet (Protego System) | Pacific Materials and Interfaces | 1998 | — |
| 0 (this device) | K012413 | Macropore FX, PS, NS, LP | Macropore Biosurgery, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K002207 | Macroporepx Pediatric SystemSummary page 3…ces: MacroPore PX Pediatric System and the MacroPore Protective Sheet (Protego System) Class I medical devices that were cleared for marketing in the United States under K002207, K972913 respectively. Indications For Use The MacroPore FX, PS, NS, LP and the predicate devices share identical indications fo… | 2001 |
| * | K972913 | Macropore Protective Sheet (Protego System)Summary page 3…oPore PX Pediatric System and the MacroPore Protective Sheet (Protego System) Class I medical devices that were cleared for marketing in the United States under K002207, K972913 respectively. Indications For Use The MacroPore FX, PS, NS, LP and the predicate devices share identical indications for use wit… | 1998 |
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 11 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 | — |
What is it indicated for?
A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1). Comminuted fractures of the naso-ethmoidal infraorbital areas. 2). Comminuted fractures of the frontal sinus wall. 3). Pediatric midface or craniofacial trauma 4). Lefort (I, II, IIT) fractures. 5). Orbital floor fractures. 6).Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the…
Read the full statement (144 words)
A. General Indications: Trauma procedures of the midface or craniofacial skeleton.
Specific Indications:
1). Comminuted fractures of the naso-ethmoidal infraorbital areas.
2). Comminuted fractures of the frontal sinus wall.
3). Pediatric midface or craniofacial trauma
4). Lefort (I, II, IIT) fractures.
5). Orbital floor fractures.
6).Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones.
B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton..
Specific Indications:
1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.).
2). Lefort (1, II, II) osteotomies.
3). Tumor reconstruction in midface or craniofacial procedures.
4). Bone graft procedures in the midface or craniofacial skeleton.
5). Pediatric reconstructive procedures.
6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
7). Craniotomy flap fixation.
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/K012413 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012413: Macropore FX, PS, NS, LP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012413
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026