FDA product code · Orthopedic · Class 2
PBF: Orthopaedic Surgical Planning And Instrument Guides
PBF is FDA's product code for "Orthopaedic Surgical Planning And Instrument Guides": a Class 2 device classified under 21 CFR 888.3030, reviewed by the Orthopedic panel.
510(k) review time for PBF
Across 24 510(k) clearances under PBF decided from 2018-01-01 to 2026-10-06, the median was 218 days from FDA receipt to decision. Half took between 122 and 281 days, and 80% were decided within 362 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 122 |
| Median | 218 |
| 75th percentile | 281 |
| 80th percentile | 362 |
| 90th percentile | 445 |
| Slowest | 509 |
| Year | Median days | n |
|---|---|---|
| 2023 | 314 | 5 |
| 2025 | 227 | 8 |
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.
PBF in the public FDA record
| GUDID device identifiers | 2,301 |
|---|
Counts of records, not of devices or events. Adverse event reports for PBF 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 PBF
No FDA recognized consensus standard cites PBF 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.