510(k) · Cleared
ClearedThe Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jun 9, 1998 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jun 9, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK980983 The Bioplate Rigid Fixation Bone Plating System for…Biomedics · 1998
- Descendant · cites it directly · 3 of its ownK062819 Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK023810 Modification to Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
- Descendant · 3 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006 · cites it directly3descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 2 generations on2descendants
- K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2002 · cites it directly1descendant
- K121606Resorb-X GKLS-Martin L.P. · 2013 · 3 generations on0descendants
- K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980983 | The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | Biomedics | 1998 | — |
| +1 | K062819 | Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery | Bioplate, Inc. | 2006 | — |
| +2 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +1 | K023810 | Modification to Bioplate Rigid Fixation Bone Plating System for… | Bioplate, Inc. | 2002 | — |
| +3 | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
| +3 | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | Porex Surgical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062819 | Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery | 2006 | 3 |
| K023810 | Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial… | 2002 | 1 |
| K994060 | The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, Biolactate | 2001 | 0 |
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, K062819 (Bioplate, Inc., 2006) has gone furthest, with 3 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 plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980983: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980983
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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