510(k) · Cleared
ClearedBurr Hole Covers, Craniomaxillofacial Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · JEY Plate, Bone
Cleared on Jan 29, 1999 after an 88-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 29, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983885 | Burr Hole Covers, Craniomaxillofacial Plates | Howmedica, Inc. | 1999 | — |
| +1 | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +2 | K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | — | Wurzburg Titanium Mini Bone Plating System Named without a submission number | |
| * | — | Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates Named without a submission number | |
| * | — | Titanium Rigid Fixation & Bone Grafting — TiMesh Inc. Named without a submission number | |
| * | — | Luhr® Pan Fixation System Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160739 | Cranial COVER | 2016 | 1 |
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, K160739 (Neos Surgery S.L, 2016) 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 | — |
What is it indicated for?
The Covers are intended for use in patients requiring craniofacial reconstruction to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps. The Plates are intended for use in patients requiring craniofacial fixation of small bones, craniofacial skeleton, midface bones and hand. These…
Read the full statement (114 words)
The Covers are intended for use in patients requiring craniofacial reconstruction to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps.
The Plates are intended for use in patients requiring craniofacial fixation of small bones, craniofacial skeleton, midface bones and hand. These plates provide structure and support following elective osteotomies and internal fixation of fractures of the hand.
The Plates are intended for use in patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provids fixation and stabilization of cranial bone flaps.
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/K983885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983885: Burr Hole Covers, Craniomaxillofacial Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983885
Report an extraction error
Are you the manufacturer?
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