510(k) · Cleared
ClearedJeil Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · JEY Plate, Bone
Cleared on May 26, 2005 as substantially equivalent to K011698 (Institut Straumann AG, 2001) and 4 other predicates after a 72-day review. Its family tree reaches back 5 generations to 1990. 8 later devices descend from it.
- Decided
- May 26, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K894844 (1990). 39 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK973353 Bonding BaseStraumann USA · 1997
- 3 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 2 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 1 generation backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- This deviceK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · cites it directly · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · cites it directly · 2 of its ownK143730 GBR SystemJeil Medical Corporation · 2015
- Descendant · cites it directly · 1 of its ownK182881 Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK160991 Neo GBR SystemNeobiotech Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK251569 Bone ScrewOsstem Implant Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170697GBR systemSurgident · 2018 · cites it directly2descendants
- K143730GBR SystemJeil Medical Corporation · 2015 · cites it directly2descendants
- K182881Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019 · cites it directly1descendant
- K160991Neo GBR SystemNeobiotech Co., Ltd. · 2017 · 2 generations on1descendant
- K251569Bone ScrewOsstem Implant Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −3 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −2 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −1 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| 0 (this device) | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +1 | K170697 | GBR system | Surgident | 2018 | — |
| +1 | K143730 | GBR System | Jeil Medical Corporation | 2015 | — |
| +1 | K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K160991 | Neo GBR System | Neobiotech Co., Ltd. | 2017 | — |
| +2 | K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K011698 | Straumann GBR SystemSummary page 1…ations 872.4760 Classification Name/Product Codes: JEY Common/Usual Name: Bone Screw, Bone Plate 2. Equivalent legally marketed devices: Straumann GBR System (K011698) Osteo-Mesh TM-300 (K984230), Dual Top Anchor System (K033767), Leforte System Plate (K023360), Leforte System Screw (K0233… | 2001 |
| * | K984230 | Osteo-Mesh TM-300Summary page 1…tion Name/Product Codes: JEY Common/Usual Name: Bone Screw, Bone Plate 2. Equivalent legally marketed devices: Straumann GBR System (K011698) Osteo-Mesh TM-300 (K984230), Dual Top Anchor System (K033767), Leforte System Plate (K023360), Leforte System Screw (K023365). 3. Indications for Use… | 1999 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…Common/Usual Name: Bone Screw, Bone Plate 2. Equivalent legally marketed devices: Straumann GBR System (K011698) Osteo-Mesh TM-300 (K984230), Dual Top Anchor System (K033767), Leforte System Plate (K023360), Leforte System Screw (K023365). 3. Indications for Use (intended use). The device is inte… | 2004 |
| * | K023360 | Leforte System Bone PlateSummary page 1…one Plate 2. Equivalent legally marketed devices: Straumann GBR System (K011698) Osteo-Mesh TM-300 (K984230), Dual Top Anchor System (K033767), Leforte System Plate (K023360), Leforte System Screw (K023365). 3. Indications for Use (intended use). The device is intended for use in stabilizing and… | 2002 |
| * | K023365 | Leforte System Bone ScrewSummary page 1…rketed devices: Straumann GBR System (K011698) Osteo-Mesh TM-300 (K984230), Dual Top Anchor System (K033767), Leforte System Plate (K023360), Leforte System Screw (K023365). 3. Indications for Use (intended use). The device is intended for use in stabilizing and fixating bone grafts, bone fil… | 2003 |
What descends from it? (8)
3 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 15 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 39 ancestors has a recall of any class.
- Of its descendants, K170697 (Surgident, 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K011698.
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 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/K050669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050669: Jeil Bone 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/K050669
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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