# K041363: Aoc Bone Wax

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Jul 27, 2004 after 67 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K791495 (1979). 2 ancestors in all.
52 later devices descend from it; 7 cite it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971680: Auto Suture Bone Wax, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.
- K791495: Lukens Bone Wax (Gamma Radiation), Lukens Corp. (1979) Summary page 1.
- (no number) Ethicon Bone Wax: named in the summary without a submission number

## Most influential descendants
- K043133: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor (2005), 43 descendants of its own
- K050440: Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 (2005), 40 descendants of its own
- 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

## Recalls of this device
- Dec 6, 2023 · Class II · Z-0658-2024: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for

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

Source page: https://510kreport.com/device/K041363
Methodology: https://510kreport.com/methodology