510(k) · Cleared
ClearedStraumann GBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · JEY Plate, Bone
Cleared on Aug 23, 2001 as substantially equivalent to K960914 (Implant Innovations, Inc., 1996) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1995. 12 later devices descend from it.
- Decided
- Aug 23, 2001
- Review
- 83 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952167 (1995). 3 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 1 generation backK960914 3I Osseous Fixation System (S)Implant Innovations, Inc. · 1996
- This deviceK011698 Straumann GBR SystemInstitut Straumann AG · 2001
- Descendant · cites it directly · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · cites it directly · 4 of its ownK063769 Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 2 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 2 generations on · 2 of its ownK143730 GBR SystemJeil Medical Corporation · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · cites it directly8descendants
- K063769Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 2 generations on3descendants
- K170697GBR systemSurgident · 2018 · 2 generations on2descendants
- K143730GBR SystemJeil Medical Corporation · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −1 | K960914 | 3I Osseous Fixation System (S) | Implant Innovations, Inc. | 1996 | — |
| 0 (this device) | K011698 | Straumann GBR System | Institut Straumann AG | 2001 | — |
| +1 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +1 | K063769 | Alpha Bio Bone Fixation Screw System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +2 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +2 | K170697 | GBR system | Surgident | 2018 | — |
| +2 | K143730 | GBR System | Jeil Medical Corporation | 2015 | — |
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 |
|---|---|---|
| 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K946165 | FDA’s K946165 is CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System Our OCR of the scanned summary read K946165, FDA’s number for CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation… (Elekta Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MODUS® System Plates, Mesh, and Screws”. Kept off the family tree. Summary page 1…IT Surgical Mesh, 21 CFR § 878.3300, Class II 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) - MODUS® System Plates, Mesh, and Screws (K946165) Implant Innovations OsseoFix System (K960914) Straumann Memfix screws (K955369) Leibinger Bone Grafting System Leibinger M-TAM T… | 1995 |
| * | K960914 | 3I Osseous Fixation System (S)Summary page 1…3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) - MODUS® System Plates, Mesh, and Screws (K946165) Implant Innovations OsseoFix System (K960914) Straumann Memfix screws (K955369) Leibinger Bone Grafting System Leibinger M-TAM TiMesh titanium mesh cribs 4. Description of t… | 1996 |
| * | K955369 | MemfixSummary page 1…hich Equivalence is Claimed (Predicate Devices) - MODUS® System Plates, Mesh, and Screws (K946165) Implant Innovations OsseoFix System (K960914) Straumann Memfix screws (K955369) Leibinger Bone Grafting System Leibinger M-TAM TiMesh titanium mesh cribs 4. Description of the Device The Straumann GBR System… | 1996 |
| * | — | Leibinger Bone Grafting System Named without a submission number | |
| * | — | Leibinger M-TAM Named without a submission number | |
| * | — | TiMesh titanium mesh cribs Named without a submission number |
What descends from it? (12)
See all 124 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 6 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050669 (Jeil Medical Corporation, 2005) has gone furthest, with 8 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.
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 Straumann Guided Bone Regeneration (GBR) System is used to stabilize and fixate
bone grafts, bone filling materials, and/or barrier membranes used for regeneration of
bone in the oral cavity. The GBR technique can make it possible for the placement of
dental implants in previously unsuitable sites.
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/K011698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011698: Straumann 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/K011698
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026