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.”
Cleared Devices (79)
| 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 |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | Mar 6, 2018 | SESE |
| K172408 | Biomet Bone Cement R | Biomet, Inc. | Oct 5, 2017 | SESE |
| K170802 | TRAUMACEM V+ Injectable Bone Cement | Synthes (USA) Products, LLC | Sep 28, 2017 | SESE |
| K171540 | Refobacin Bone Cement R | Biomet, Inc. | Aug 30, 2017 | SESE |
| K153737 | OSTEOPAL plus | Heraeus Medical GmbH | Apr 22, 2016 | SESE |
| K150408 | V-STEADY, V-FAST | G21, S.R.L. | Dec 14, 2015 | SESE |
| K150119 | PALACOS R pro | Heraeus Medical GmbH | Jun 17, 2015 | SESE |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | Mar 5, 2015 | SESE |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | Cossington, Ltd. | Mar 5, 2015 | SESE |
| K142157 | PALACOS R+G PRO | Heraeus Medical GmbH | Sep 5, 2014 | SESE |
| K123225 | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 | Aap Biomaterials GmbH & Co. KG | Mar 15, 2013 | SESE |
| K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 | Aap Biomaterials GmbH & Co. KG | Mar 7, 2013 | SESE |
| K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | Tecres S.P.A. | Nov 24, 2009 | SESE |
| K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | Biomet, Inc. | Oct 27, 2009 | SESE |
| K091608 | COBALT MV BONE CEMENT | Biomet Manufacturing Corp | Sep 17, 2009 | SESE |
| K081155 | SMARTSET MV BONE CEMENT | DePuy Orthopaedics, Inc. | May 14, 2008 | SESE |
| K070015 | COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT | Biomet Manufacturing Corp | Nov 30, 2007 | SESE |
| K062553 | SIMPLEX P BONE CEMENT | Stryker Orthopaedics | Jan 8, 2007 | SESE |
| K053198 | SIMPLEX P SPEEDSET BONE CEMENT | Howmedica Osteonics Corp. | Jan 26, 2006 | SESE |
| K053445 | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT | DePuy Orthopaedics, Inc. | Jan 6, 2006 | SESE |
| K053003 | DEPUY CMW 1, 2 AND 3 BONE CEMENTS | DePuy Orthopaedics, Inc. | Nov 22, 2005 | SESE |
| K050085 | OSTEOPAL V | Heraeus Kulzer,GmbH | Sep 14, 2005 | SESE |
| K051496 | COBALT BONE CEMENT | Biomet, Inc. | Aug 4, 2005 | SESE |
| K051532 | COBALT G HV BONE CEMENT | Biomet, Inc. | Aug 3, 2005 | SESE |
| K050855 | PALAMED G | Heraeus Kulzer,GmbH | Jul 7, 2005 | SESE |
| K050854 | PALACOS LV+G | Heraeus Kulzer,GmbH | Jul 7, 2005 | SESE |
| K043403 | CEMEX SYSTEM GENTA FAST BONE CEMENT | Exactech, Inc. | Dec 28, 2004 | SESE |
| K041656 | MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | Jul 1, 2004 | SESE |
| K032945 | SIMPLEX X | Stryker Corp. | May 25, 2004 | SESE |
| K031673 | REFOBACIN -PALACOS G | Heraeus Kulzer GmbH & Co. KG | May 25, 2004 | SESE |
| K033596 | CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT | Exactech, Inc. | May 10, 2004 | SESE |
| K022688 | VERSABOND AB BONE CEMENT | Smith & Nephew, Inc. | Apr 29, 2004 | SESE |
| K033563 | SMARTSET GHV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | Feb 5, 2004 | SESE |
| K033382 | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | Feb 5, 2004 | SESE |
| K030086 | PALACOS R BONE CEMENT WITH GENTAMICIN | Biomet, Inc. | Dec 17, 2003 | SESE |
| K033509 | MODIFICATION TO VERSABOND BONE CEMENT | Smith & Nephew, Inc. | Nov 28, 2003 | SESE |
| K023103 | DEPUY 1 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | Sep 29, 2003 | SESE |
| K030904 | PALAMED | Heraeus Medical GmbH Technology | Sep 23, 2003 | SESE |
| K030903 | OSTEOPAL | Heraeus Kulzer GmbH & Co. KG | Sep 23, 2003 | SESE |
| K030902 | PALACOS R | Heraeus Kulzer GmbH & Co. KG | Sep 23, 2003 | SESE |
| K031430 | CEMEX SYSTEM FAST | Exactech, Inc. | May 22, 2003 | SESE |
| K014199 | SURGICAL SIMPLEX P WITH TOBRAMYCIN | Howmedica Osteonics Corp. | May 6, 2003 | SESE |
| K022251 | PALABOND | Heraeus Kulzer GmbH & Co. KG | Feb 26, 2003 | SESE |
| K023012 | SMARTSET HV BONE CEMENT | DePuy Orthopaedics, Inc. | Feb 13, 2003 | SESE |
| K021499 | CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT | DePuy Orthopaedics, Inc. | Jul 24, 2002 | SESE |
| K021715 | CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL | Exactech, Inc. | Jun 12, 2002 | SESE |
| K013755 | CONCERT RADIOPAQUE BONE CEMENT | Immedica, Inc. | Feb 8, 2002 | SESE |
| K993836 | GENERATION 4 BONE CEMENT | Biomet, Inc. | Dec 19, 2001 | SESE |
| K010586 | PALAMED BONE CEMENT | Merck Biomaterial GmbH | Oct 30, 2001 | SESE |
| K000943 | CEMEX SYSTEM GUN APPLICATION VERSION | Exactech, Inc. | Feb 8, 2001 | SESE |
| K002652 | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII | Stryker Corp. | Jan 26, 2001 | SESE |
| K001160 | VERSABOND BONE CEMENT | Smith & Nephew, Inc. | Dec 11, 2000 | SESE |
| P960001 | DEPUY 1 BONE CEMENT | Depuy, Inc. | Feb 11, 1997 | APRL |
| N18466 | CMW BONE CEMENT | Depuy, Inc. | Feb 22, 1984 | APRL |
| P810020 | PALACOS R BONE CEMENT | Smith & Nephew Richards, Inc. | Feb 2, 1984 | APRL |
| N17113 | OMNIPLASTIC BONE CEMENT | L.D. Caulk Co. | Sep 16, 1981 | APRL |
| N17755 | ZIMMER(R) BONE CEMENT | Zimmer, Inc. | May 17, 1976 | APRL |
| N17004 | SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT | Howmedica Corp. | Oct 7, 1971 | APRL |
| N17003 | SURGICAL SIMPLED P BONE CEMENT | Howmedica Corp. | Oct 7, 1971 | APRL |
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
