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., United States Surgical, A Division of Tyco Healthc and Aesculap, Inc..

42
Total
42
Cleared
143d
Avg days
1979
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 34d recently vs 146d historically

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

42 devices
1–24 of 42
Cleared Jun 03, 2026
Permatage Flowable, Settable Hemostatic Bone Paste
K261439
Orthocon, Inc.
Orthopedic · 34d
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
Cleared Mar 27, 2020
HBP6 Settable, Resorbable Hemostatic Bone Paste
K193052
Orthocon, Inc.
General & Plastic Surgery · 147d
Cleared Jul 18, 2019
MONTAGE-QS Settable, Resorbable Hemostatic Bone
K191140
Orthocon, Inc.
General & Plastic Surgery · 79d
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

About Product Code MTJ - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code MTJ since 1979, with 42 receiving FDA clearance (average review time: 143 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - MTJ Product Code

Recent submissions under MTJ have taken an average of 34 days to reach a decision - down from 146 days historically, suggesting improved FDA processing for this classification.

MTJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →