# K180249: OmniPore DUROMAX Surgical Implants

- Pathway: 510(k) (Traditional)
- Applicant: Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Decided: Oct 11, 2018 after 255 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 K031761 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.

Source page: https://510kreport.com/device/K180249
Methodology: https://510kreport.com/methodology