# K103822: Synthes Hemostatic Bone Putty (HBP)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: May 19, 2011 after 140 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K791495 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082491: Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene, Ceremed, Inc. (2008) Summary page 1.

## Recalls of this device
- Jul 5, 2012 · Class I · Z-2206-2012: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

## Indications for use
Synthes Hemostatic Bone Putty 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/K103822
Methodology: https://510kreport.com/methodology