# K091807: Medpor Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Jun 28, 2010 after 375 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: 4 generations back to K954385 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021642: Synthes Craniofacial Plates, Synthes (Usa) (2002) Summary page 1.
- K963546: SMF Titanium (TI) Alloy Bone Screws, Synthes (Usa) (1997) Summary page 1.
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 1.

## Indications for use
The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System For Maxillofacial Surgery is intended for single use.

Source page: https://510kreport.com/device/K091807
Methodology: https://510kreport.com/methodology