FDA product code · Orthopedic · Class 2
PML: Bone Cement, Posterior Screw Augmentation
PML is FDA's product code for "Bone Cement, Posterior Screw Augmentation": a Class 2 device classified under 21 CFR 888.3027, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for PML
Across 16 510(k) clearances under PML decided from 2018-01-01 to 2026-10-06, the median was 135 days from FDA receipt to decision. Half took between 93 and 186 days, and 80% were decided within 199 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 93 |
| Median | 135 |
| 75th percentile | 186 |
| 80th percentile | 199 |
| 90th percentile | 232 |
| Slowest | 275 |
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.
PML in the public FDA record
| Establishment listings | 149 |
|---|---|
| GUDID device identifiers | 2,019 |
Counts of records, not of devices or events. Adverse event reports for PML 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 PML
No FDA recognized consensus standard cites PML 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.