# K984230: Osteo-Mesh TM-300

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Feb 4, 1999 after 71 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
Longest line of descent: 1 generation back to K963394 (1996). 1 ancestor in all.
30 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963394: Osteomed Tram, Osteomed Corp. (1996) Summary page 1.

## Most influential descendants
- 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
- K140600: SB Anchor (2014), 4 descendants of its own

## Indications for use
For stabilization and support of bone grafts in dento-alveolar bony defect sites.

Source page: https://510kreport.com/device/K984230
Methodology: https://510kreport.com/methodology