# K161446: Biopor Porous Polyethylene Implants

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Sep 27, 2016 after 125 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- 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 K141880 (2015). 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)
- K141880: Biopor Aoc Porous Polyethylene, Cerepor, Ceremed, Inc. (2015) Summary page 4.

## Indications for use
Biopor Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

Source page: https://510kreport.com/device/K161446
Methodology: https://510kreport.com/methodology