FDA Product Code MTJ: Wax, Bone
FDA product code MTJ covers bone wax used as a hemostatic agent during bone surgery.
This beeswax-based material is applied to bleeding bone surfaces to mechanically seal the intraosseous vessels in the bone marrow. It is used in craniotomy, sternotomy, and orthopedic procedures where conventional hemostatic techniques are insufficient for controlling bone bleeding.
MTJ devices are reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Orthocon, Inc., Ceremed , Inc. and Cp Medical.
42
Total
42
Cleared
143d
Avg days
1979
Since
42 devices
Cleared
Jul 22, 2011
MP 719
Marine Polymer Technologies, Inc.
General & Plastic Surgery
50d
Cleared
May 19, 2011
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
Synthes USA Products, LLC
General & Plastic Surgery
140d
Cleared
Feb 15, 2011
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
Orthocon, Inc.
General & Plastic Surgery
144d
Cleared
Oct 08, 2010
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
Ceremed , Inc.
General & Plastic Surgery
77d
Cleared
Jun 22, 2009
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
Ceremed , Inc.
General & Plastic Surgery
18d
Cleared
Apr 28, 2009
ORTHOSTAT
Orthocon, Inc.
General & Plastic Surgery
11d
Cleared
Sep 24, 2008
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
Ceremed , Inc.
General & Plastic Surgery
27d
Cleared
Nov 22, 2006
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
Orthocon, Inc.
General & Plastic Surgery
19d
Cleared
Nov 02, 2006
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
Cp Medical
General & Plastic Surgery
206d
Cleared
Oct 11, 2005
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
Ceremed , Inc.
General & Plastic Surgery
27d
Cleared
Aug 12, 2005
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
Orthocon, LLC
General & Plastic Surgery
261d
Cleared
Mar 24, 2005
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
Ceremed , Inc.
General & Plastic Surgery
30d
Cleared
Mar 09, 2005
SHARPOINT LUKENS BONE WAX
Surgical Specialties Corp
General & Plastic Surgery
30d
Cleared
Jul 27, 2004
AOC BONE WAX
Ceremed , Inc.
General & Plastic Surgery
67d
Cleared
Jun 19, 2003
CP MEDICAL BONE WAX
Cp Medical
General & Plastic Surgery
170d
Cleared
Mar 24, 2000
AESCULAP BONE WAX
Aesculap, Inc.
General & Plastic Surgery
80d
Cleared
Oct 24, 1997
AUTO SUTURE BONE WAX
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
170d