510(k) · Cleared
ClearedBioplate 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
Bioplate, Inc. · JEY Plate, Bone
Cleared on Apr 8, 2003 as substantially equivalent to K013954 (Walter Lorenz Surgical, Inc., 2002) and 5 other predicates after a 26-day review. Its family tree reaches back 6 generations to 1976. 5 later devices descend from it.
- Decided
- Apr 8, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K761228 (1976). 19 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 4 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 3 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 2 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 1 generation backK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
- This deviceK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 3 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc. · 2010 · cites it directly4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · cites it directly3descendants
- K170697GBR systemSurgident · 2018 · 2 generations on2descendants
- K222367Save GBRDentis Co., Ltd. · 2023 · 3 generations on0descendants
- K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −5 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −2 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −1 | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating… | Bioplate, Inc. | 2002 | — |
| 0 (this device) | K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | Bioplate, Inc. | 2003 | — |
| +1 | K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible… | Frontier Devices, Inc. | 2010 | — |
| +1 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +2 | K170697 | GBR system | Surgident | 2018 | — |
| +3 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +3 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (6)
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 |
|---|---|---|---|
| * | K013954 | Lorenz Self Drilling Screws | 2002 |
| * | K983485 | Synthes 1.3 MM Self-Drilling ScrewSummary page 1…vices (1) Walter Lorenz Surgical Instruments, Inc. Lorenz Self Drilling Screw KO13954 (2) Synthes (USA) Self Drilling Screw K983485 (3) KLS-Martin L.P. Centre-Drive Drill Free Screw K971297 (4) Osteomed Corp. Auto-Drive Bone S… | 1998 |
| * | K971297 | Centre-Drive Drill-Free ScrewSummary page 1…illing Screw KO13954 (2) Synthes (USA) Self Drilling Screw K983485 (3) KLS-Martin L.P. Centre-Drive Drill Free Screw K971297 (4) Osteomed Corp. Auto-Drive Bone Screw K974785 (5) Bioplate, Inc. BioplateB Rigid Fix… | 1997 |
| * | K974785 | Auto-Drive Bone ScrewSummary page 1…ing Screw K983485 (3) KLS-Martin L.P. Centre-Drive Drill Free Screw K971297 (4) Osteomed Corp. Auto-Drive Bone Screw K974785 (5) Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K9… | 1998 |
| * | K972463 | The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgerySummary page 2…Auto-Drive Bone Screw K974785 (5) Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463/K022890 Description of the device The BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes ti… | 1997 |
| * | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Summary page 2…-Drive Bone Screw K974785 (5) Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463/K022890 Description of the device The BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium a… | 2002 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K091812 (Frontier Devices, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K013954.
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 BioplateB 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-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The supplementary IabeVlabeling material will be used for training and promotional purposes and does not affect the intended use of the devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030806: 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 6, 2026. https://510kreport.com/device/K030806
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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