# K141880: Biopor Aoc Porous Polyethylene, Cerepor

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Apr 16, 2015 after 279 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K161446: Biopor Porous Polyethylene Implants (2016), 0 descendants of its own
- K160988: Biopor, AOC Porous Polyethylene, Cerepor (2016), 0 descendants of its own

## Indications for use
Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Source page: https://510kreport.com/device/K141880
Methodology: https://510kreport.com/methodology