510(k) · Cleared
Cleared3I Osseous Fixation System (S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Innovations, Inc. · JEY Plate, Bone
Cleared on Apr 4, 1996 as substantially equivalent to K955369 (The Straumann Co., 1996) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1995. 13 later devices descend from it.
- Decided
- Apr 4, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952167 (1995). 2 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- This deviceK960914 3I Osseous Fixation System (S)Implant Innovations, Inc. · 1996
- Descendant · cites it directly · 12 of its ownK011698 Straumann GBR SystemInstitut Straumann AG · 2001
- Descendant · 2 generations on · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · 2 generations on · 4 of its ownK063769 Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 3 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K011698Straumann GBR SystemInstitut Straumann AG · 2001 · cites it directly12descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · 2 generations on8descendants
- K063769Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007 · 2 generations on4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 3 generations on3descendants
- K170697GBR systemSurgident · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| 0 (this device) | K960914 | 3I Osseous Fixation System (S) | Implant Innovations, Inc. | 1996 | — |
| +1 | K011698 | Straumann GBR System | Institut Straumann AG | 2001 | — |
| +2 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +2 | K063769 | Alpha Bio Bone Fixation Screw System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +3 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +3 | K170697 | GBR system | Surgident | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K955369 | MemfixSummary page 4…e membranes in GBR procedures with and without endosseous dental implants. SUBSTANTIAL EQUIVALENCE: Straumann USA "Memfix" The Mini-Screw Membrane Fixation Kit" System K955369. IMZ/Interpore Bone Tack System K952167. Both IMZ and Straumann may have received a determination of Substantial Equivalence on… | 1996 |
| * | K952167 | Imz Bone Tack SystemSummary page 4…thout endosseous dental implants. SUBSTANTIAL EQUIVALENCE: Straumann USA "Memfix" The Mini-Screw Membrane Fixation Kit" System K955369. IMZ/Interpore Bone Tack System K952167. Both IMZ and Straumann may have received a determination of Substantial Equivalence on their respective systems for use with La… | 1995 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011698 | Straumann GBR System | 2001 | 12 |
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?
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?
NON-RESORBABLE MEMBRANE FIXATION FOR ENDOSSEOUS DENTAL IMPLANT AND/OR GUIDED TISSUE REGENERATION PROCEDURES, USING OSSEOUS FIXATION (PLATE AND SCREW) SYSTEMS.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960914: 3I Osseous Fixation System (S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960914
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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