Skip to content

Synthes Hemostatic Bone Putty

by Synthes (Usa) Products, LLC/Norian Corporation 510(k)

Active United States

510(k) K113079

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113079 Date13 Dec 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-2206-2012 FDA Class I initiated 5 Jul 2012

    There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

    • Terminated Z-1094-2015 FDA Class II initiated 6 Jan 2012

    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.

Specification

510(k)

510(k) Number
FDA Product Code
MTJ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent