# K133461: Stryker Universal Orbital Floor System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Aug 1, 2014 after 262 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). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123786: Stryker Universal Orbital Floor System, Stryker (2013) Summary page 5.

## Most influential descendants
- K142568: Stryker MEDPOR TITAN 3D Orbital Floor Implant (2015), 0 descendants of its own

## Indications for use
The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.

Source page: https://510kreport.com/device/K133461
Methodology: https://510kreport.com/methodology