510(k) · Cleared
ClearedNeo Titanium Mesh, Cti-Mem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neobiotech Co., Ltd. · JEY Plate, Bone
Cleared on Jan 10, 2012 as substantially equivalent to K984230 (Osteogenics Biomedical, Inc., 1999) after a 201-day review. Its family tree reaches back 2 generations to 1996. 17 later devices descend from it.
- Decided
- Jan 10, 2012
- Review
- 201 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963394 (1996). 17 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK963394 Osteomed TramOsteomed Corp. · 1996
- 1 generation backK984230 Osteo-Mesh TM-300Osteogenics Biomedical, Inc. · 1999
- This deviceK111761 Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd. · 2012
- Descendant · cites it directly · 14 of its ownK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
- Descendant · 2 generations on · 3 of its ownK172354 OssBuilder SystemOsstem Implant Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK231411 INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K120951Smartbuilder SystemOsstem Implant Co., Ltd. · 2012 · cites it directly14descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 2 generations on6descendants
- K140600SB AnchorOsstem Implant Co., Ltd. · 2014 · 2 generations on4descendants
- K172354OssBuilder SystemOsstem Implant Co., Ltd. · 2018 · 2 generations on3descendants
- K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963394 | Osteomed Tram | Osteomed Corp. | 1996 | — |
| −1 | K984230 | Osteo-Mesh TM-300 | Osteogenics Biomedical, Inc. | 1999 | — |
| 0 (this device) | K111761 | Neo Titanium Mesh, Cti-Mem | Neobiotech Co., Ltd. | 2012 | — |
| +1 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +2 | K140600 | SB Anchor | Osstem Implant Co., Ltd. | 2014 | — |
| +2 | K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018 | — |
| +3 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K984230 | Osteo-Mesh TM-300Summary page 1…Common Name - Titanium Ridge Augmentation Mesh Classification Name - Bone Plate 3. Predicate Device: Osteo-Mesh TM-300, K984230, Osteogenics Biomedical 4. Device Classification: JEY, CFRS72.4760, Class 2 5. Device Descr… | 1999 |
What descends from it? (17)
See all 174 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 16 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120951 (Osstem Implant Co., Ltd., 2012) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K984230.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111761: Neo Titanium Mesh, Cti-Mem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111761
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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