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. and M/s. Meril Endo Surgery Private Limited..

41
Total
41
Cleared
146d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Wax, Bone Devices (Product Code MTJ)

41 devices
1–24 of 41
Cleared Oct 12, 2023
Montage- XT Settable, Resorbable Hemostatic Bone Putty
K232998
Orthocon, Inc.
Orthopedic · 20d
Cleared Aug 30, 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K213418
Orthocon, Inc.
General & Plastic Surgery · 679d
Cleared Jul 11, 2023
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
K231386
Orthocon, Inc.
Orthopedic · 60d
Cleared Mar 27, 2023
Meril-Bonewax
K200452
M/s. Meril Endo Surgery Private Limited.
Orthopedic · 1127d
Cleared Mar 11, 2022
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
K220315
Orthocon, Inc.
Orthopedic · 36d
Cleared Jan 19, 2021
HBP7 Settable Hemostatic Bone Putty
K202363
Orthocon, Inc.
General & Plastic Surgery · 153d

About Product Code MTJ - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code MTJ since 1979, with 41 receiving FDA clearance (average review time: 146 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.

MTJ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →