FDA product code MTJ: Wax, Bone
MTJ is the FDA product code for wax, bone. It is a Unclassified device, reviewed by the Orthopedic panel. FDA has cleared 43 510(k) submissions under MTJ, 7 in the last five years, from 16 different applicants. The average 510(k) review took 141 days (median 79); 32 days on average over the last three years. FDA has posted 4 recalls for MTJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Wax, Bone |
| Device class | Unclassified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MTJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 79 |
| 2020 | 1 | 147 |
| 2021 | 1 | 153 |
| 2022 | 1 | 36 |
| 2023 | 4 | 472 |
| 2026 | 2 | 32 |
Compare with all 510(k) review times · Search every MTJ clearance
Top MTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthocon, Inc. | 21 | 2026-09-03 |
| Ceremed , Inc. | 6 | 2010-10-08 |
| Orthocon, LLC | 2 | 2014-09-26 |
| Cp Medical | 2 | 2006-11-02 |
| M/s. Meril Endo Surgery Private Limited. | 1 | 2023-03-27 |
11 more applicants have MTJ clearances. See the full list in Caduvo.
Most recent MTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262769 | Orthocon, Inc. | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | 2026-09-03 | 30 |
| K261439 | Orthocon, Inc. | Permatage Flowable, Settable Hemostatic Bone Paste | 2026-06-03 | 34 |
| K232998 | Orthocon, Inc. | Montage- XT Settable, Resorbable Hemostatic Bone Putty | 2023-10-12 | 20 |
| K213418 | Orthocon, Inc. | MONTAGE Settable, Resorbable Hemostatic Bone Putty | 2023-08-30 | 679 |
| K231386 | Orthocon, Inc. | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | 2023-07-11 | 60 |
Recalls for MTJ devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-06.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code MTJ?
MTJ is the FDA product code for wax, bone. It is a Unclassified device, reviewed by the Orthopedic panel.
What device class is MTJ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MTJ?
Across 43 cleared submissions the average was 141 days from receipt to decision (median 79).
Which companies have the most MTJ clearances?
Orthocon, Inc. (21); Ceremed , Inc. (6); Orthocon, LLC (2); Cp Medical (2); M/s. Meril Endo Surgery Private Limited. (1).
Have MTJ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2023-12-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MTJ
- Run a recall and safety report across every MTJ manufacturer
- Watch product code MTJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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