# K113079: Synthes Hemostatic Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa) Products, LLC/Norian Corporation
- Decided: Dec 13, 2011 after 57 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- Recalls of this device: 2 (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.
5 later devices descend from it; 2 cite it directly.
1 of 19 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.

## Most influential descendants
- K122156: Orthocon Absorbable Hemostatic Bone Putty (2013), 3 descendants of its own
- K140117: Ahbppress Absorbable Hemostatic Bone Putty (2014), 2 descendants of its own
- K142348: OsteoSeal Bone Hemostat (2015), 0 descendants of its own
- K143069: HEMASORBPLUS press Resorable Hemostatic Bone Putty (2014), 0 descendants of its own
- K142339: HEMASORB Resorbable Hemostatic Bone Putty (2014), 0 descendants of its own

## 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.
- Jan 6, 2012 · Class II · Z-1094-2015: Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.

## 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/K113079
Methodology: https://510kreport.com/methodology