510(k) · Cleared
Recalled · 2006The Bioplate Resorbable Endobrow Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioplate, Inc. · JEY Plate, Bone
Cleared on Jul 27, 2005 as substantially equivalent to K012908 (Bioplate, Inc., 2001) after a 20-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 27, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K012908 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K061507Sonicweld RX Endobrow FixationKLS-Martin L.P. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012908 | Bioplate Resorbable Bone Screw | Bioplate, Inc. | 2001 | — |
| 0 (this device) | K051845 | The Bioplate Resorbable Endobrow Fixation System | Bioplate, Inc. | 2005 | — |
| +1 | K061507 | Sonicweld RX Endobrow Fixation | KLS-Martin L.P. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K996040 | The Bioplate Resorbable Bone Plating System For Craniomaxillofacial Surgery… Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…21 CFR 888,3040 Predicate Devices: (1.) Bioplate, Inc. The Bioplate Resorbable Bone Plating System For Cranlomaxillofacial Surgery, Biolactate TM (K996040) (2.) Bioplate, Inc. The Bloplate Resorbable Bone Screw (KO12908) 9 === Page… | |
| * | K012908 | Bioplate Resorbable Bone ScrewSummary page 2…ted to brow fixation has some minor modifications to the Indications for Use; but has become more restrictive than the Indications for Use as the Bioplate (K994060) and (K012908). All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061507 | Sonicweld RX Endobrow Fixation | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2006 | Not classified | Z-0043-2007 | Other | Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061507 (KLS-Martin L.P., 2006) has gone furthest, with 0 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 Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051845: The Bioplate Resorbable Endobrow Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051845
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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