MBB — Bone Cement, Antibiotic Class II
FDA product code MBB covers "Bone Cement, Antibiotic", a Class II medical device regulated under 21 CFR 888.3027. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MBB
- Device Class
- Class II
- Regulation Number
- 888.3027
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252443 | g21 | SpaceFix Shoulder Spacer | September 15, 2025 |
| K242216 | teknimed | GENTAFIX® (1, 3, 3MV) | December 18, 2024 |
| K240856 | osartis | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | November 20, 2024 |
| K222760 | biomet | StageOne Select Hip Cement Spacer Molds | December 28, 2022 |
| K221968 | biomet | StageOne Shoulder Cement Spacer Molds | September 15, 2022 |
| K213287 | biomet | StageOne Knee Cement Spacer Molds | September 2, 2022 |
| K202338 | g21 | SpaceFlex Shoulder | February 17, 2021 |
| K201960 | g21 | SpaceFlex Knee - 80mm Size | August 13, 2020 |
| K192041 | g21 | G21 SpaceFlex Hip | October 29, 2019 |
| K190216 | g21 | SpaceFlex Knee | June 9, 2019 |
| K161273 | biomet | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | January 25, 2017 |
| K161166 | biomet | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | September 8, 2016 |
| K160071 | biomet | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | June 16, 2016 |
| K150850 | biomet | Refobacin Bone Cement R | July 16, 2015 |
| K131135 | biomet manufacturing | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROS | January 22, 2014 |
| K081163 | depuy orthopaedics | SMARTSET GMV GENTAMICIN BONE CEMENT | May 14, 2008 |
| K063857 | howmedica osteonics | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | February 26, 2007 |
| K061144 | depuy orthopaedics | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | June 8, 2006 |
| K053002 | depuy orthopaedics | DEPUY CMW 1 GENTAMICIN BONE CEMENT | November 22, 2005 |