# K160988: Biopor, AOC Porous Polyethylene, Cerepor

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Jul 14, 2016 after 97 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
Longest line of descent: 3 generations back to K922489 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K140437: SU-Por Surgical Implant, Poriferous, LLC (2014) Summary page 4.
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla, Porex Technologies Corp. (1992) Summary page 4.

## 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/K160988
Methodology: https://510kreport.com/methodology