Bone Cement, Antibiotic
FDA product code MBB · Class II (moderate risk) · 21 CFR 888.3027 · Orthopedic
19510(k) clearances
0PMA approvals
5recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252443 | SpaceFix Shoulder SpacerMBB · Traditional | G21, S.R.L. | 09/15/2025SE |
| K242216 | Gentafix® (1, 3, 3MV)MBB · Traditional | Teknimed Sas | 12/18/2024SE |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsMBB · Traditional | Osartis GmbH | 11/20/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | Biomet, Inc. | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | Biomet, Inc. | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | Biomet, Inc. | 09/02/2022SE |
| K202338 | SpaceFlex ShoulderMBB · Traditional | G21, S.R.L. | 02/17/2021SE |
| K201960 | SpaceFlex Knee - 80mm SizeMBB · Special | G21, S.R.L. | 08/13/2020SE |
| K192041 | G21 SpaceFlex HipMBB · Traditional | G21, S.R.L. | 10/29/2019SE |
| K190216 | SpaceFlex KneeMBB · Traditional | G21, S.R.L. | 06/09/2019SE |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisMBB · Traditional | Biomet, Inc. | 01/25/2017SE |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip ReplacementMBB · Traditional | Biomet, Inc. | 09/08/2016SE |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisMBB · Traditional | Biomet, Inc. | 06/16/2016SE |
| K150850 | Refobacin Bone Cement RMBB · Traditional | Biomet, Inc. | 07/16/2015SE |
| K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisMBB · Traditional | Biomet Manufacturing Corp | 01/22/2014SE |
| K081163 | Smartset GMV Gentamicin Bone CementMBB · Special | DePuy Orthopaedics, Inc. | 05/14/2008SE |
| K063857 | Simplex P Speedset with Tobramycin Bone CementMBB · Traditional | Howmedica Osteonics Corp. | 02/26/2007SE |
| K061144 | Depuy CMW 2 and CMW 3 Gentamicin Bone CementMBB · Traditional | DePuy Orthopaedics, Inc. | 06/08/2006SE |
| K053002 | Depuy CMW 1 Gentamicin Bone CementMBB · Special | DePuy Orthopaedics, Inc. | 11/22/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0240-2023 Class II | Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number:…Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered… | Howmedica Osteonics Corp. | 10/21/2022Open, Classified |
| Z-1246-2015 Class II | SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate…One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical… | DePuy Orthopaedics, Inc. | 02/11/2015Terminated |
| Z-0730-2014 Class II | Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl…The patient label associated with the product may be incorrect in that the lot number on the patient label… | Zimmer, Inc. | 11/04/2013Terminated |
| Z-0064-2014 Class II | SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone…The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in… | DePuy Orthopaedics, Inc. | 09/16/2013Terminated |
| Z-0467-2007 | Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.The expiration date on the external label is incorrect in that it does not identify the earliest expiration… | Stryker Howmedica Osteonics Corp. | 11/07/2006Terminated |