# K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Dec 11, 2006 after 126 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: 5 generations back to K791495 (1979). 10 ancestors in all.
38 later devices descend from it; 3 cite it directly.
2 of 49 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.
- K041363: Aoc Bone Wax, Ceremed, Inc. (2004) Summary page 1.
- K052528: Aoc Bone Wax Ostene, Osteotene and Ceretene, Ceremed, Inc. (2005) Summary page 1.

## Most influential descendants
- K070093: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste (2007), 29 descendants of its own
- K082491: Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene (2008), 28 descendants of its own
- K091636: Ostene CT, Aoc CT, Osteotene, Ceretene (2009), 20 descendants of its own
- K111538: Skaffold Cis (2011), 18 descendants of its own
- K102071: Ostene CT, Aoc CT, Osteotene, Ceretene (2010), 17 descendants of its own

## Indications for use
OSTENE® is indicated for use as a water-soluble implant material for use in the control of bleeding from bone surfaces and as a water-soluble space occupying material as an adjunct during the natural healing process.

Source page: https://510kreport.com/device/K062280
Methodology: https://510kreport.com/methodology