# K050440: Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12

- Pathway: 510(k) (Special)
- Applicant: Ceremed, Inc.
- Decided: Mar 24, 2005 after 30 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- 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 K791495 (1979). 3 ancestors in all.
40 later devices descend from it; 1 cites it directly.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041363: Aoc Bone Wax, Ceremed, Inc. (2004) Summary page 1.

## Most influential descendants
- K052528: Aoc Bone Wax Ostene, Osteotene and Ceretene (2005), 39 descendants of its own
- K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste (2006), 38 descendants of its own
- 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

## Indications for use
AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.

Source page: https://510kreport.com/device/K050440
Methodology: https://510kreport.com/methodology