# K142568: Stryker MEDPOR TITAN 3D Orbital Floor Implant

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: May 5, 2015 after 235 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: 3 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)
- K133461: Stryker Universal Orbital Floor System, Stryker (2014) Summary page 4.

## Indications for use
The MEDPOR TITAN® 3D Orbital Floor Implant 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/K142568
Methodology: https://510kreport.com/methodology