FDA product code · Orthopedic · Class U
MTJ: Wax, Bone
MTJ is FDA's product code for "Wax, Bone": a Class U device, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for MTJ
Across 10 510(k) clearances under MTJ decided from 2018-01-01 to 2026-10-06, the median was 70 days from FDA receipt to decision. Half took between 35 and 152 days, and 80% were decided within 258 days. These are past clearances, not a forecast for a new submission.
| Fastest | 20 |
|---|---|
| 25th percentile | 35 |
| Median | 70 |
| 75th percentile | 152 |
| 80th percentile | 258 |
| 90th percentile | 724 |
| Slowest | 1,127 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MTJ in the public FDA record
| 510(k) clearances, all years | 43 |
|---|---|
| Establishment listings | 104 |
Counts of records, not of devices or events. Adverse event reports for MTJ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MTJ
No FDA recognized consensus standard cites MTJ by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.