510(k) · Cleared
ClearedGBR system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on May 24, 2018 as substantially equivalent to K141764 (Impladent, Ltd., 2014) and 1 other predicate after a 443-day review. Its family tree reaches back 9 generations to 1976. 2 later devices descend from it.
- Decided
- May 24, 2018
- Review
- 443 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K761228 (1976). 80 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations between
- 3 generations backK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
- 2 generations backK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- 1 generation backK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- This deviceK170697 GBR systemSurgident · 2018
- Descendant · cites it directly · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 8 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 7 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 6 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 5 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 4 generations backK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
- 3 generations backK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
- 2 generations backK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- 1 generation backK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- This deviceK170697 GBR systemSurgident · 2018
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 |
|---|---|---|---|---|---|
| −9 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −8 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −7 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −5 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −4 | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating… | Bioplate, Inc. | 2002 | — |
| −3 | K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | Bioplate, Inc. | 2003 | — |
| −2 | K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible… | Frontier Devices, Inc. | 2010 | — |
| −1 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| 0 (this device) | K170697 | GBR system | Surgident | 2018 | — |
| +1 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +1 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K141764 | Tristar Bone Graft Fixation SystemSummary page 4…lass of device : Class II 8) Panel : Dental 3. The legally marketed device to which we are claiming equivalence : Predicate Devices: Primary Predicate : K141764, TriStar Bone Graft Fixation System / Impladent Ltd. Reference Pred… | 2014 |
| * | K050669 | Jeil Bone Fixation SystemSummary page 4…Primary Predicate : K141764, TriStar Bone Graft Fixation System / Impladent Ltd. Reference Predicate : K050669, Jeil Bone Fixation system / Jeil Medical Corporation Reference Pre… | 2005 |
| † | K011698 | Straumann GBR System | 2001 |
What descends from it? (2)
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 42 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 80 ancestors have a recall of any class.
- Of its descendants, K222367 (Dentis Co., Ltd., 2023) has gone furthest, with 0 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. 2018, 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 device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170697: GBR system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170697
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