510(k) · Cleared
ClearedTristar Bone Graft Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impladent, Ltd. · JEY Plate, Bone
Cleared on Dec 18, 2014 as substantially equivalent to K073342 (Salvin Dental Specialties, Inc., 2008) and 6 other predicates after a 170-day review. Its family tree reaches back 8 generations to 1976. 3 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 170 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K761228 (1976). 43 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 7 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 6 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 5 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 4 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 3 generations backK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
- 2 generations backK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
- 1 generation backK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- This deviceK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 2 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −7 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −4 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −3 | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating… | Bioplate, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +1 | K170697 | GBR system | Surgident | 2018 | — |
| +2 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +2 | 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 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K073342 | Salvin Dental Specialties, Inc., Fixation ScrewSummary page 4…riStar Bone Graft Fixation System Predicate Devices Screws: Salvin Titanium Fixation Screw System (K073342) Frontier Devices Maxillofacial and Mesh System (K091812)… | 2008 |
| * | K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Summary page 4…ces Screws: Salvin Titanium Fixation Screw System (K073342) Frontier Devices Maxillofacial and Mesh System (K091812) BioPlate Rigid Fixation Bone Plating System for… | 2010 |
| * | K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgerySummary page 4…BioPlate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K030806, K972463, K022890) Alpha-Bio Tec Bone Fixation Screw System (K063769) Pr… | 2003 |
| * | K972463 | The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgerySummary page 4…BioPlate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K030806, K972463, K022890) Alpha-Bio Tec Bone Fixation Screw System (K063769) Predicate D… | 1997 |
| * | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Summary page 4…BioPlate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K030806, K972463, K022890) Alpha-Bio Tec Bone Fixation Screw System (K063769) Predicate Devices Me… | 2002 |
| * | K063769 | Alpha Bio Bone Fixation Screw SystemSummary page 4…Craniomaxillofacial Surgery (K030806, K972463, K022890) Alpha-Bio Tec Bone Fixation Screw System (K063769) Predicate Devices Mesh: Unicare Biomedical Cytoflex Mesh (K021511) 718 465-1810… | 2007 |
| * | K021511 | Cytoflex MeshSummary page 4…Alpha-Bio Tec Bone Fixation Screw System (K063769) Predicate Devices Mesh: Unicare Biomedical Cytoflex Mesh (K021511) 718 465-1810 800 526-9343 Fax: 718 465-962 ==… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170697 | GBR system | 2018 | 2 |
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 38 years and passes through 7 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K170697 (Surgident, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K073342.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141764: Tristar Bone Graft Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141764
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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