# K081531: Aoc Soluble Implant Material

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Jul 18, 2008 after 46 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K791495 (1979). 12 ancestors in all.
5 later devices descend from it; 3 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)
- K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste, Ceremed, Inc. (2006) Summary page 1.
- K080507: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Ceremed, Inc. (2008)

## Most influential descendants
- K120220: Adaptain Soluble Implant Material (2012), 2 descendants of its own
- K122561: Adaptain Fastwrap, Envelock, Graftain (2012), 1 descendant of its own
- K132198: Adaptain, Adaptain Fastwrap, Envelock, Biowai (2013), 0 descendants of its own
- K103047: Ceretene Soluble Implant Material (2011), 0 descendants of its own
- K082245: Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LV (2008), 0 descendants of its own

## Indications for use
space occupying material, as an adjunct during the natural healing process.

Source page: https://510kreport.com/device/K081531
Methodology: https://510kreport.com/methodology