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., G21, S.R.L. and DePuy Orthopaedics, Inc..

19
Total
19
Cleared
129d
Avg days
2005
Since
Stable submission activity - 3 submissions in the last 2 years
Consistent review times: 140d avg (recent)

FDA 510(k) Cleared Bone Cement, Antibiotic Devices (Product Code MBB)

19 devices
1–19 of 19
Cleared Sep 15, 2025
SpaceFix Shoulder Spacer
K252443
G21, S.R.L.
Orthopedic · 42d
Cleared Dec 18, 2024
GENTAFIX® (1, 3, 3MV)
K242216
Teknimed Sas
Orthopedic · 142d
Cleared Nov 20, 2024
Hip Spacer Molds
K240856
Osartis GmbH
Orthopedic · 237d
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
Cleared Feb 17, 2021
SpaceFlex Shoulder
K202338
G21, S.R.L.
Orthopedic · 184d
Cleared Aug 13, 2020
SpaceFlex Knee - 80mm Size
K201960
G21, S.R.L.
Orthopedic · 30d
Cleared Oct 29, 2019
G21 SpaceFlex Hip
K192041
G21, S.R.L.
Orthopedic · 90d
Cleared Jun 09, 2019
SpaceFlex Knee
K190216
G21, S.R.L.
Orthopedic · 125d
Cleared Jan 25, 2017
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K161273
Biomet, Inc.
Orthopedic · 265d
Cleared Sep 08, 2016
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166
Biomet, Inc.
Orthopedic · 135d
Cleared Jun 16, 2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071
Biomet, Inc.
Orthopedic · 155d
Cleared Jul 16, 2015
Refobacin Bone Cement R
K150850
Biomet, Inc.
Orthopedic · 107d
Cleared May 14, 2008
SMARTSET GMV GENTAMICIN BONE CEMENT
K081163
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Feb 26, 2007
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
K063857
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Jun 08, 2006
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
K061144
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Nov 22, 2005
DEPUY CMW 1 GENTAMICIN BONE CEMENT
K053002
DePuy Orthopaedics, Inc.
Orthopedic · 27d

About Product Code MBB - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code MBB since 2005, with 19 receiving FDA clearance (average review time: 129 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - MBB Product Code

FDA review times for MBB submissions have been consistent, averaging 140 days recently vs 127 days historically.

MBB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →