FDA product code · Orthopedic · Class 2
MBB: Bone Cement, Antibiotic
MBB is FDA's product code for "Bone Cement, Antibiotic": 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 MBB
Across 10 510(k) clearances under MBB decided from 2018-01-01 to 2026-10-06, the median was 116 days from FDA receipt to decision. Half took between 77 and 174 days, and 80% were decided within 195 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 77 |
| Median | 116 |
| 75th percentile | 174 |
| 80th percentile | 195 |
| 90th percentile | 247 |
| Slowest | 336 |
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.
MBB in the public FDA record
| Establishment listings | 148 |
|---|
Counts of records, not of devices or events. Adverse event reports for MBB 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 MBB
4 FDA recognized consensus standards cite MBB, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F983-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.