# K140978: Osteomed Low Profile Orbital Floor Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: Dec 18, 2014 after 246 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: 2 generations back to K080331 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031761: Synthes (Usa) New/Sterial Orbital Plates, Synthes (Usa) (2003) Summary page 4.
- K123786: Stryker Universal Orbital Floor System, Stryker (2013) Summary page 4.

## Indications for use
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit. The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.

Source page: https://510kreport.com/device/K140978
Methodology: https://510kreport.com/methodology