MBB · Bone Cement, Antibiotic
Orthopedic · 21 CFR 888.3027 · Class 2
Overview
| Product Code | MBB |
|---|---|
| Device Name | Bone Cement, Antibiotic |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | Sep 15, 2025 | SESE |
| K242216 | GENTAFIX® (1, 3, 3MV) | Teknimed Sas | Dec 18, 2024 | SESE |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | Nov 20, 2024 | SESE |
| K222760 | StageOne Select Hip Cement Spacer Molds | Biomet, Inc. | Dec 28, 2022 | SESE |
| K221968 | StageOne Shoulder Cement Spacer Molds | Biomet, Inc. | Sep 15, 2022 | SESE |
| K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | Sep 2, 2022 | SESE |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | Feb 17, 2021 | SESE |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | Aug 13, 2020 | SESE |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | Oct 29, 2019 | SESE |
| K190216 | SpaceFlex Knee | G21, S.R.L. | Jun 9, 2019 | SESE |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | Biomet, Inc. | Jan 25, 2017 | SESE |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Biomet, Inc. | Sep 8, 2016 | SESE |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | Jun 16, 2016 | SESE |
| K150850 | Refobacin Bone Cement R | Biomet, Inc. | Jul 16, 2015 | SESE |
| K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS | Biomet Manufacturing Corp | Jan 22, 2014 | SESE |
| K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | May 14, 2008 | SESE |
| K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | Howmedica Osteonics Corp. | Feb 26, 2007 | SESE |
| K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | Jun 8, 2006 | SESE |
| K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | Nov 22, 2005 | SESE |
Top Applicants
- Biomet, Inc. — 7 clearances
- G21, S.R.L. — 5 clearances
- DePuy Orthopaedics, Inc. — 3 clearances
- Teknimed Sas — 1 clearance
- Osartis GmbH — 1 clearance
