# K070093: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste

- Pathway: 510(k) (Special)
- Applicant: Ceremed, Inc.
- Decided: Jan 24, 2007 after 14 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). 11 ancestors in all.
29 later devices descend from it; 1 cites it directly.
2 of 41 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.

## Most influential descendants
- 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
- K102071: Ostene CT, Aoc CT, Osteotene, Ceretene (2010), 17 descendants of its own
- K141502: HBP4 Hardening, Resorbable Hemostatic Bone Putty (2014), 13 descendants of its own
- K152005: MONTAGE Settable, Resorbable Hemostatic Bone Putty (2015), 12 descendants of its own

## Indications for use
OSTENE® is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Source page: https://510kreport.com/device/K070093
Methodology: https://510kreport.com/methodology