# K971680: Auto Suture Bone Wax

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Oct 24, 1997 after 170 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: 1 generation back to K791495 (1979). 1 ancestor in all.
55 later devices descend from it; 8 cite it directly.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791495: Lukens Bone Wax (Gamma Radiation), Lukens Corp. (1979) Summary page 1.
- (no number) Ethicon™ Bone Wax (preamendment): named in the summary without a submission number

## Most influential descendants
- K041363: Aoc Bone Wax (2004), 52 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K971680
Methodology: https://510kreport.com/methodology