# K963394: Osteomed Tram

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Nov 14, 1996 after 78 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984230: Osteo-Mesh TM-300 (1999), 30 descendants of its own
- K111761: Neo Titanium Mesh, Cti-Mem (2012), 17 descendants of its own
- K120951: Smartbuilder System (2012), 14 descendants of its own
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own

Source page: https://510kreport.com/device/K963394
Methodology: https://510kreport.com/methodology