MTJ

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
25–42 of 42
Cleared Jul 22, 2011
MP 719
K111524
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 50d
Cleared May 19, 2011
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
K103822
Synthes USA Products, LLC
General & Plastic Surgery · 140d
Cleared Feb 15, 2011
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
K102762
Orthocon, Inc.
General & Plastic Surgery · 144d
Cleared Oct 08, 2010
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K102071
Ceremed , Inc.
General & Plastic Surgery · 77d
Cleared Jun 22, 2009
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K091636
Ceremed , Inc.
General & Plastic Surgery · 18d
Cleared Apr 28, 2009
ORTHOSTAT
K091121
Orthocon, Inc.
General & Plastic Surgery · 11d
Cleared Sep 24, 2008
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
K082491
Ceremed , Inc.
General & Plastic Surgery · 27d
Cleared Nov 22, 2006
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K063330
Orthocon, Inc.
General & Plastic Surgery · 19d
Cleared Nov 02, 2006
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
K060987
Cp Medical
General & Plastic Surgery · 206d
Cleared Oct 11, 2005
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
K052528
Ceremed , Inc.
General & Plastic Surgery · 27d
Cleared Aug 12, 2005
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
K043260
Orthocon, LLC
General & Plastic Surgery · 261d
Cleared Mar 24, 2005
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K050440
Ceremed , Inc.
General & Plastic Surgery · 30d
Cleared Mar 09, 2005
SHARPOINT LUKENS BONE WAX
K050292
Surgical Specialties Corp
General & Plastic Surgery · 30d
Cleared Jul 27, 2004
AOC BONE WAX
K041363
Ceremed , Inc.
General & Plastic Surgery · 67d
Cleared Jun 19, 2003
CP MEDICAL BONE WAX
K024372
Cp Medical
General & Plastic Surgery · 170d
Cleared Mar 24, 2000
AESCULAP BONE WAX
K000021
Aesculap, Inc.
General & Plastic Surgery · 80d
Cleared Oct 24, 1997
AUTO SUTURE BONE WAX
K971680
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 170d