510(k) · Cleared
ClearedFrontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frontier Devices, Inc. · JEY Plate, Bone
Cleared on May 7, 2010 as substantially equivalent to K030806 (Bioplate, Inc., 2003) and 3 other predicates after a 323-day review. Its family tree reaches back 7 generations to 1976. 4 later devices descend from it.
- Decided
- May 7, 2010
- Review
- 323 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K761228 (1976). 31 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 3 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 2 generations backK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
- 1 generation backK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
- This deviceK091812 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −7 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −6 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −3 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −2 | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating… | Bioplate, Inc. | 2002 | — |
| −1 | K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | Bioplate, Inc. | 2003 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgerySummary page 1…Panel: Dental Predicate Devices Frontier Devices Moxillofacial System BioPlate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K030806) Frontier Devices Appendix D K091812 -… | 2003 |
| * | K031989 | Ortrautek Orthognathic SystemSummary page 2…Letter Page D-1 Frontier Devices Orthognothic System Ortrautek Orthognathic System (K031989) Frontier Devices Mandible Reconstruction System BioPlate Mandible Fixation System (K012910) Frontier Devices Mesh System Synth… | 2003 |
| * | K012910 | The Bioplate Mandible Fixation SystemSummary page 2…ge 2 === Frontier Devices Orthognothic System Ortrautek Orthognathic System (K031989) Frontier Devices Mandible Reconstruction System BioPlate Mandible Fixation System (K012910) Frontier Devices Mesh System Synthes Craniofacial Plate and Screw System (K050608) Device Descriptions Frontier Devices Maxill… | 2001 |
| * | K050608 | Synthes Carniofacial Plate and Screw SystemSummary page 2…) Frontier Devices Mandible Reconstruction System BioPlate Mandible Fixation System (K012910) Frontier Devices Mesh System Synthes Craniofacial Plate and Screw System (K050608) Device Descriptions Frontier Devices Maxillofaciol System The devices in the Maxillofacial System are implantable bone plates a… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141764 | Tristar Bone Graft Fixation System | 2014 | 3 |
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 34 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K141764 (Impladent, Ltd., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K030806.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and…
Read the full statement (122 words)
Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Frontier Devices Mandible Reconstructive System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Frontier Devices Mesh System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091812
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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