MBB — Bone Cement, Antibiotic Class II
FDA Device Classification
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 |