510(k) · Cleared
ClearedOsteo-Mesh TM-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteogenics Biomedical, Inc. · JEY Plate, Bone
Cleared on Feb 4, 1999 as substantially equivalent to K963394 (Osteomed Corp., 1996) after a 71-day review. Its family tree reaches back 1 generation to 1996. 30 later devices descend from it.
- Decided
- Feb 4, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963394 (1996). 30 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK963394 Osteomed TramOsteomed Corp. · 1996
- This deviceK984230 Osteo-Mesh TM-300Osteogenics Biomedical, Inc. · 1999
- Descendant · cites it directly · 17 of its ownK111761 Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd. · 2012
- Descendant · 2 generations on · 14 of its ownK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · 3 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K111761Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd. · 2012 · cites it directly17descendants
- K120951Smartbuilder SystemOsstem Implant Co., Ltd. · 2012 · 2 generations on14descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · cites it directly8descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 3 generations on6descendants
- K140600SB AnchorOsstem Implant Co., Ltd. · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963394 | Osteomed Tram | Osteomed Corp. | 1996 | — |
| 0 (this device) | K984230 | Osteo-Mesh TM-300 | Osteogenics Biomedical, Inc. | 1999 | — |
| +1 | K111761 | Neo Titanium Mesh, Cti-Mem | Neobiotech Co., Ltd. | 2012 | — |
| +2 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +3 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +3 | K140600 | SB Anchor | Osstem Implant Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 6 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K963394 | Osteomed TramSummary page 1…teo-Mesh™ TM-300 Common Name: Titanium Ridge Augmentation Mesh Classification Name: Bone Plate PREDICATE DEVICE OsteoMed TRAM™ (Titanium Ridge Augmentation Material); K963394; OsteoMed Corporation. DEVICE DESCRIPTION The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 t… | 1996 |
What descends from it? (30)
See all 305 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?
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?
For stabilization and support of bone grafts in dento-alveolar bony defect 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/K984230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984230: Osteo-Mesh TM-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984230
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