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..

5
Total
5
Cleared
190d
Avg days
2021
Since

List of Wax, Bone devices cleared through 510(k)

5 devices
1–5 of 5
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 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

How to use this database

This page lists all FDA 510(k) submissions for Wax, Bone devices (product code MTJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →