510(k) · Cleared
Recalled · 2008Lactosorb Panels and Fasteners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JEY Plate, Bone
Cleared on Jun 5, 1998 after an 86-day review. The FDA summary names no predicate by number. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 5, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK980927 Lactosorb Panels and FastenersBiomet, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK983360 Macropore Protective SheetPacific Materials and Interfaces · 1999
- Descendant · 2 generations on · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K983360Macropore Protective SheetPacific Materials and Interfaces · 1999 · cites it directly6descendants
- K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002 · 2 generations on5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980927 | Lactosorb Panels and Fasteners | Biomet, Inc. | 1998 | — |
| +1 | K983360 | Macropore Protective Sheet | Pacific Materials and Interfaces | 1999 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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), 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?
The FDA summary names no predicate by number.
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2008 | Not classified | Z-1872-2008 | Packaging process control | The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983360 (Pacific Materials and Interfaces, 1999) has gone furthest, with 6 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 | — |
What is it indicated for?
The LactoSorb Panels and Fasteners are used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal 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/K980927 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980927: Lactosorb Panels and Fasteners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980927
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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