# K080507: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Apr 21, 2008 after 56 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: 4 generations back to K791495 (1979). 8 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043133: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor, Ceremed, Inc. (2005) Summary page 1.
- K040364: Medpor Craniofacial Implants with Embedded Titanium Mesh, Porex Surgical, Inc. (2004) Summary page 1.

## Most influential descendants
- K081531: Aoc Soluble Implant Material (2008), 5 descendants of its own
- K120220: Adaptain Soluble Implant Material (2012), 2 descendants of its own
- K111323: Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants (2011), 2 descendants of its own
- K133809: Osteofab Patient Specific Facial Device (2014), 1 descendant of its own
- K122561: Adaptain Fastwrap, Envelock, Graftain (2012), 1 descendant of its own

## Indications for use
AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

Source page: https://510kreport.com/device/K080507
Methodology: https://510kreport.com/methodology