LOD · Bone Cement
Orthopedic · 21 CFR 888.3027 · Class 2
Overview
| Product Code | LOD |
|---|---|
| Device Name | Bone Cement |
| 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.”
Recent Cleared Devices (20 of 79)
Showing 20 most recent of 79 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | Apr 15, 2026 | SESE |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | Apr 2, 2025 | SESE |
| K241674 | OSTEOPAL® V | Heraeus Medical GmbH | Dec 5, 2024 | SESE |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | Dec 20, 2023 | SESE |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | Jan 9, 2023 | SESE |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | May 31, 2022 | SESE |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | May 19, 2022 | SESE |
| K213812 | PALACOS MV pro | Heraeus Medical GmbH | Feb 2, 2022 | SESE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | Jul 9, 2021 | SESE |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | May 18, 2021 | SESE |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | Mar 19, 2021 | SESE |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | Mar 19, 2021 | SESE |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Heraeus Medical GmbH | Nov 23, 2020 | SESE |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | Mar 19, 2020 | SESE |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | Mar 19, 2020 | SESE |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | Dec 2, 2019 | SESE |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | Nov 27, 2019 | SESE |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | May 31, 2019 | SESE |
| K181282 | G3A 40 Bone Cement | G21, S.R.L. | Jan 9, 2019 | SESE |
| K182260 | PALACOS MV | Heraeus Medical GmbH | Sep 17, 2018 | SESE |
Top Applicants
- Heraeus Medical GmbH — 9 clearances
- DePuy Orthopaedics, Inc. — 9 clearances
- Biomet, Inc. — 7 clearances
- Osartis GmbH — 5 clearances
- G21, S.R.L. — 5 clearances
