510(k) · Cleared
ClearedOsteomed Tram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · JEY Plate, Bone
Cleared on Nov 14, 1996 after a 78-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 39 later devices descend from it.
- Decided
- Nov 14, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 3 citing it directly.
- This deviceK963394 Osteomed TramOsteomed Corp. · 1996
- Descendant · cites it directly · 30 of its ownK984230 Osteo-Mesh TM-300Osteogenics Biomedical, Inc. · 1999
- Descendant · 2 generations on · 17 of its ownK111761 Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd. · 2012
- Descendant · 3 generations on · 14 of its ownK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · 4 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K984230Osteo-Mesh TM-300Osteogenics Biomedical, Inc. · 1999 · cites it directly30descendants
- K111761Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd. · 2012 · 2 generations on17descendants
- K120951Smartbuilder SystemOsstem Implant Co., Ltd. · 2012 · 3 generations on14descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · 2 generations on8descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963394 | Osteomed Tram | Osteomed Corp. | 1996 | — |
| +1 | K984230 | Osteo-Mesh TM-300 | Osteogenics Biomedical, Inc. | 1999 | — |
| +2 | K111761 | Neo Titanium Mesh, Cti-Mem | Neobiotech Co., Ltd. | 2012 | — |
| +3 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +4 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (39)
See all 393 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?
- Of its descendants, K984230 (Osteogenics Biomedical, Inc., 1999) has gone furthest, with 30 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 | — |
https://510kreport.com/device/K963394 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963394: Osteomed Tram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963394
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026