MBB · Class II · 21 CFR 888.3027

FDA Product Code MBB: Bone Cement, Antibiotic

FDA product code MBB covers antibiotic-impregnated bone cements used in orthopedic surgery.

These cements incorporate antibiotics — typically gentamicin or tobramycin — directly into the PMMA matrix, providing sustained local antibiotic elution at the implant-bone interface. They are used to reduce the risk of periprosthetic joint infection and as spacers in the treatment of established infections.

MBB devices are Class II medical devices, regulated under 21 CFR 888.3027 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Biomet, Inc..

3
Total
3
Cleared
171d
Avg days
2022
Since

List of Bone Cement, Antibiotic devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Dec 28, 2022
StageOne™ Select Hip Cement Spacer Molds
K222760
Biomet, Inc.
Orthopedic · 106d
Cleared Sep 15, 2022
StageOne™ Shoulder Cement Spacer Molds
K221968
Biomet, Inc.
Orthopedic · 72d
Cleared Sep 02, 2022
StageOne Knee Cement Spacer Molds
K213287
Biomet, Inc.
Orthopedic · 336d

How to use this database

This page lists all FDA 510(k) submissions for Bone Cement, Antibiotic devices (product code MBB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →