Product code MBB
- Device name
- Bone Cement, Antibiotic
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3027
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025-09-15 |
| K242216 | GENTAFIX® (1, 3, 3MV) | Teknimed Sas | 2024-12-18 |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024-11-20 |
| K222760 | StageOne™ Select Hip Cement Spacer Molds | Biomet, Inc. | 2022-12-28 |
| K221968 | StageOne™ Shoulder Cement Spacer Molds | Biomet, Inc. | 2022-09-15 |
| K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | 2022-09-02 |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021-02-17 |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020-08-13 |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019-10-29 |
| K190216 | SpaceFlex Knee | G21, S.R.L. | 2019-06-09 |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | Biomet, Inc. | 2017-01-25 |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Biomet, Inc. | 2016-09-08 |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016-06-16 |
| K150850 | Refobacin Bone Cement R | Biomet, Inc. | 2015-07-16 |
| K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS | Biomet Manufacturing Corp | 2014-01-22 |
| K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2008-05-14 |
| K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | Howmedica Osteonics Corp. | 2007-02-26 |
| K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2006-06-08 |
| K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2005-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08031497004006 | Interspace GV Hip Spacer 60 XL | TECRES SPA | 2026-02-11 |
| 08031497003993 | Interspace GV Hip Spacer 54 XL | TECRES SPA | 2026-02-11 |
| 08031497003955 | Interspace GV Hip Spacer 46 | TECRES SPA | 2026-02-11 |
| 08031497003962 | Interspace GV Hip Spacer 54 | TECRES SPA | 2026-02-11 |
| 08031497003979 | Interspace GV Hip Spacer 60 | TECRES SPA | 2026-02-11 |
| 08031497003986 | Interspace GV Hip Spacer 46 XL | TECRES SPA | 2026-02-11 |
| 08058964729026 | BRAVO HV+G | G21 SRL | 2024-09-16 |
| 08058964729019 | BRAVO MV+G | G21 SRL | 2024-09-16 |
| 08058964728746 | Arthrex Bone Cement MV w/G | G21 SRL | 2024-09-16 |
| 08058964728722 | Arthrex Bone Cement HV w/G | G21 SRL | 2024-09-16 |
| 08031497002101 | Conflow G Bone Cement | TECRES SPA | 2021-06-09 |
| 08031497002149 | MectaCem-X LV with Gentamicin | TECRES SPA | 2021-06-09 |
| 08031497002163 | MectaCem-X HV with Gentamicin | TECRES SPA | 2021-06-09 |
| 08058964726889 | SpaceFlex Hip | G21 SRL | 2019-11-04 |
| 08058964726902 | SpaceFlex Hip | G21 SRL | 2019-11-04 |
| 08058964720122 | G3A 40 Bone Cement | G21 SRL | 2019-03-08 |
| 08058964726759 | OrthoSteady G | G21 SRL | 2018-05-03 |
| 07613327128451 | Simplex | Howmedica Osteonics Corp. | 2017-06-19 |
| 08031497001586 | Interspace Tapered Wedge Stem | TECRES SPA | 2015-10-12 |
| 08031497001630 | Interspace Tapered Wedge Stem | TECRES SPA | 2015-10-12 |
| 08031497001623 | Interspace Tapered Wedge Stem | TECRES SPA | 2015-10-12 |
| 08031497001616 | Interspace Tapered Wedge Stem | TECRES SPA | 2015-10-12 |
| 08031497001609 | Interspace Tapered Wedge Stem | TECRES SPA | 2015-10-12 |
| 08031497001593 | Interspace Tapered Wedge Stem | TECRES SPA | 2015-10-12 |
| 10603295168324 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168331 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168355 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295174264 | NA | DEPUY (IRELAND) | 2015-09-24 |
| J014001113140011 | PALACOS | Heraeus Medical GmbH | 2015-06-01 |
| J014001119140011 | PALACOS | Heraeus Medical GmbH | 2015-06-01 |