510(k) · Cleared
Recalled · Class II · 2018Lactosorb Rapidflap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JEY Plate, Bone
Cleared on Aug 7, 2001 after a 292-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2001
- Review
- 292 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK003281 Lactosorb RapidflapBiomet, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK130309 Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013
- Descendant · cites it directly · 1 of its ownK073115 OrthomeshSynthes (Usa) · 2008
- Descendant · 2 generations on · 0 of its ownK221606 Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK180821 TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013 · cites it directly1descendant
- K073115OrthomeshSynthes (Usa) · 2008 · cites it directly1descendant
- K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023 · 2 generations on0descendants
- K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003281 | Lactosorb Rapidflap | Biomet, Inc. | 2001 | — |
| +1 | K130309 | Rapidflap LS Cranial Flap Fixation System | Biomet Microfixation | 2013 | — |
| +1 | K073115 | Orthomesh | Synthes (Usa) | 2008 | — |
| +2 | K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023 | — |
| +2 | K180821 | TruMatch Graft Cage - Long Bone | Synthes (Usa), LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|---|
| Apr 5, 2018 | Class II | Z-1705-2018 | Process control | The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130309 (Biomet Microfixation, 2013) has gone furthest, with 1 descendant 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/K003281 · printed Nov 3, 2026
Cite this page
510(k) Report. “K003281: Lactosorb Rapidflap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003281
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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