Panels › Orthopedic › Product code MBB · Class 2
Bone Cement, Antibiotic
Regulation 888.3027
0510(k)s in 12 months (19 all time)
2recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in MBB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2025 | K252443 | SpaceFix Shoulder Spacer G21, S.R.L., IT | MBB |
| Dec 18, 2024 | K242216 | GENTAFIX® (1, 3, 3MV) Teknimed Sas, FR | MBB |
| Nov 20, 2024 | K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds Osartis GmbH, DE | MBB |
| Dec 28, 2022 | K222760 | StageOne Select Hip Cement Spacer Molds Biomet, Inc. | MBB |
| Sep 15, 2022 | K221968 | StageOne Shoulder Cement Spacer Molds Biomet, Inc. | MBB |
| Sep 2, 2022 | K213287 | StageOne Knee Cement Spacer Molds Biomet, Inc. | MBB |
| Feb 17, 2021 | K202338 | SpaceFlex Shoulder G21, S.R.L., IT | MBB |
| Aug 13, 2020 | K201960 | SpaceFlex Knee - 80mm Size G21, S.R.L., IT | MBB |
| Oct 29, 2019 | K192041 | G21 SpaceFlex Hip G21, S.R.L., IT | MBB |
| Jun 9, 2019 | K190216 | SpaceFlex Knee G21, S.R.L., IT | MBB |
| Jan 25, 2017 | K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis Biomet, Inc. | MBB |
| Sep 8, 2016 | K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement Biomet, Inc. | MBB |
| Jun 16, 2016 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Biomet, Inc. | MBB |
| Jul 16, 2015 | K150850 | Refobacin Bone Cement R Biomet, Inc. | MBB |
| Jan 22, 2014 | K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS Biomet Manufacturing Corp | MBB |
| May 14, 2008 | K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. | MBB |
| Feb 26, 2007 | K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT Howmedica Osteonics Corp. | MBB |
| Jun 8, 2006 | K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. | MBB |
| Nov 22, 2005 | K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. | MBB |
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