Bone Cement
FDA product code LOD · Class II (moderate risk) · 21 CFR 888.3027 · Orthopedic
72510(k) clearances
2PMA approvals
33recalls
Implantimplanted device
Manufacturers
- DePuy Orthopaedics, Inc. 9
- Heraeus Medical GmbH 9
- Biomet, Inc. 7
- Heraeus Kulzer, Inc. 7
- Exactech, Inc. 5
- Osartis GmbH 5
- G21, S.R.L. 5
- Smith & Nephew, Inc. 3
- Stryker Corporation 2
- Osteoremedies, LLC 2
- Cossington, Ltd. 2
- Aap Biomaterials GmbH & Co. KG 2
- Tecres S.P.A. 2
- Biomet Manufacturing Corp 2
- Howmedica Osteonics Corp. 2
- Stryker Orthopaedics 1
- Heraeus Medical GmbH Technology 1
- Synthes (USA) Products LLC 1
- Immedica, Inc. 1
- Biomet France 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355)LOD · Traditional | Biomet France | 04/15/2026SE |
| K250760 | SPECTRUM GV Bone CementLOD · Special | Osteoremedies, LLC | 04/02/2025SE |
| K241674 | Osteopal® VLOD · Traditional | Heraeus Medical GmbH | 12/05/2024SE |
| K231556 | SPECTRUM® GV Bone CementLOD · Traditional | Osteoremedies, LLC | 12/20/2023SE |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional | Tecres S.P.A. | 01/09/2023SE |
| K212729 | Bone Cement-Normal ViscosityLOD · Traditional | Biomecanica Industria E Comerciode Produtos… | 05/31/2022SE |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…LOD · Traditional | Ormed Grup Medikal Turizm Saglik Hizmetleri… | 05/19/2022SE |
| K213812 | PALACOS MV proLOD · Traditional | Heraeus Medical GmbH | 02/02/2022SE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional | Heraeus Medical GmbH | 07/09/2021SE |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusherLOD · Traditional | Osartis GmbH | 05/18/2021SE |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional | Osartis GmbH | 03/19/2021SE |
| K210120 | BonOs HV, BonOs MV, BonOs LVLOD · Traditional | Osartis GmbH | 03/19/2021SE |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD · Traditional | Heraeus Medical GmbH | 11/23/2020SE |
| K193061 | G3 40 Radiopaque Bone CementLOD · Traditional | G21, S.R.L. | 03/19/2020SE |
| K193059 | G1 40 Radiopaque Bone CementLOD · Traditional | G21, S.R.L. | 03/19/2020SE |
| K192394 | Hi-Fatigue Bone CementLOD · Traditional | Osartis GmbH | 12/02/2019SE |
| K192379 | Hi-Fatigue G Bone CementLOD · Traditional | Osartis GmbH | 11/27/2019SE |
| K190766 | PALACOS fast R+GLOD · Traditional | Heraeus Medical GmbH | 05/31/2019SE |
| K181282 | G3A 40 Bone CementLOD · Traditional | G21, S.R.L. | 01/09/2019SE |
| K182260 | Palacos MVLOD · Special | Heraeus Medical GmbH | 09/17/2018SE |
| K173494 | OrthoSteady G Bone CementLOD · Traditional | G21, S.R.L. | 03/06/2018SE |
| K172408 | Biomet Bone Cement RLOD · Traditional | Biomet, Inc. | 10/05/2017SE |
| K170802 | TRAUMACEM V+ Injectable Bone CementLOD · Traditional | Synthes (USA) Products, LLC | 09/28/2017SE |
| K171540 | Refobacin Bone Cement RLOD · Traditional | Biomet, Inc. | 08/30/2017SE |
| K153737 | OSTEOPAL plusLOD · Special | Heraeus Medical GmbH | 04/22/2016SE |
| K150408 | V-Steady, V-FastLOD · Traditional | G21, S.R.L. | 12/14/2015SE |
| K150119 | PALACOS R proLOD · Special | Heraeus Medical GmbH | 06/17/2015SE |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemLOD · Traditional | Cossington, Ltd. | 03/05/2015SE |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaLOD · Traditional | Cossington, Ltd. | 03/05/2015SE |
| K142157 | Palacos R+G ProLOD · Special | Heraeus Medical GmbH | 09/05/2014SE |
| K123225 | Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60LOD · Abbreviated | Aap Biomaterials GmbH & Co. KG | 03/15/2013SE |
| K123081 | Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40…LOD · Abbreviated | Aap Biomaterials GmbH & Co. KG | 03/07/2013SE |
| K092773 | Cemex Genta, Genta System and Genta System FastLOD · Special | Tecres S.P.A. | 11/24/2009SE |
| K092150 | Cobalt MV with Gentamicin (Aka Cobalt G-Mv) Bone CementLOD · Traditional | Biomet, Inc. | 10/27/2009SE |
| K091608 | Cobalt MV Bone CementLOD · Traditional | Biomet Manufacturing Corp | 09/17/2009SE |
| K081155 | Smartset MV Bone CementLOD · Special | DePuy Orthopaedics, Inc. | 05/14/2008SE |
| K070015 | Cobalt V Radiopaque Vertebroplasty Bone CementLOD · Abbreviated | Biomet Manufacturing Corp | 11/30/2007SE |
| K062553 | Simplex P Bone CementLOD · Traditional | Stryker Orthopaedics | 01/08/2007SE |
| K053198 | Simplex P Speedset Bone CementLOD · Traditional | Howmedica Osteonics Corp. | 01/26/2006SE |
| K053445 | Smartmix Cemvac Pre-Filled with Smartset HV Bone CementLOD · Traditional | DePuy Orthopaedics, Inc. | 01/06/2006SE |
| K053003 | Depuy CMW 1, 2 and 3 Bone CementsLOD · Special | DePuy Orthopaedics, Inc. | 11/22/2005SE |
| K050085 | Osteopal VLOD · Abbreviated | Heraeus Kulzer,GmbH | 09/14/2005SE |
| K051496 | Cobalt Bone CementLOD · Traditional | Biomet, Inc. | 08/04/2005SE |
| K051532 | Cobalt G HV Bone CementLOD · Traditional | Biomet, Inc. | 08/03/2005SE |
| K050855 | Palamed GLOD · Traditional | Heraeus Kulzer,GmbH | 07/07/2005SE |
| K050854 | Palacos Lv+GLOD · Traditional | Heraeus Kulzer,GmbH | 07/07/2005SE |
| K043403 | Cemex System Genta Fast Bone CementLOD · Special | Exactech, Inc. | 12/28/2004SE |
| K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…LOD · Special | DePuy Orthopaedics, Inc. | 07/01/2004SE |
| K032945 | Simplex XLOD · Traditional | Stryker Corp. | 05/25/2004SE |
| K031673 | Refobacin -Palacos GLOD · Traditional | Heraeus Kulzer GmbH & Co. KG | 05/25/2004SE |
| K033596 | Cemex Genta Bone Cement; Cemex Genta System Bone CementLOD · Traditional | Exactech, Inc. | 05/10/2004SE |
| K022688 | Versabond AB Bone CementLOD · Abbreviated | Smith & Nephew, Inc. | 04/29/2004SE |
| K033563 | Smartset GHV Gentamicin Bone CementLOD · Traditional | DePuy Orthopaedics, Inc. | 02/05/2004SE |
| K033382 | Smartset GMV Endurance Gentamicin Bone CementLOD · Traditional | DePuy Orthopaedics, Inc. | 02/05/2004SE |
| K030086 | Palacos R Bone Cement with GentamicinLOD · Traditional | Biomet, Inc. | 12/17/2003SE |
| K033509 | Modification to Versabond Bone CementLOD · Special | Smith & Nephew, Inc. | 11/28/2003SE |
| K023103 | Depuy 1 Gentamicin Bone CementLOD · Traditional | DePuy Orthopaedics, Inc. | 09/29/2003SE |
| K030904 | PalamedLOD · Abbreviated | Heraeus Medical GmbH Technology | 09/23/2003SE |
| K030903 | OsteopalLOD · Abbreviated | Heraeus Kulzer GmbH & Co. KG | 09/23/2003SE |
| K030902 | Palacos RLOD · Abbreviated | Heraeus Kulzer GmbH & Co. KG | 09/23/2003SE |
| K031430 | Cemex System FastLOD · Special | Exactech, Inc. | 05/22/2003SE |
| K014199 | Surgical Simplex P with TobramycinLOD · Traditional | Howmedica Osteonics Corp. | 05/06/2003SE |
| K022251 | PalabondLOD · Abbreviated | Heraeus Kulzer GmbH & Co. KG | 02/26/2003SE |
| K023012 | Smartset HV Bone CementLOD · Traditional | DePuy Orthopaedics, Inc. | 02/13/2003SE |
| K021499 | Cemvac Ultra Pre-Packed with Depuy 1 Bone CementLOD · Traditional | DePuy Orthopaedics, Inc. | 07/24/2002SE |
| K021715 | Cemex RX, Cemex Isoplastic & Cemex XLLOD · Special | Exactech, Inc. | 06/12/2002SE |
| K013755 | Concert Radiopaque Bone CementLOD · Traditional | Immedica, Inc. | 02/08/2002SE |
| K993836 | Generation 4 Bone CementLOD · Traditional | Biomet, Inc. | 12/19/2001SE |
| K010586 | Palamed Bone CementLOD · Traditional | Merck Biomaterial GmbH | 10/30/2001SE |
| K000943 | Cemex System Gun Application VersionLOD · Traditional | Exactech, Inc. | 02/08/2001SE |
| K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiLOD · Traditional | Stryker Corp. | 01/26/2001SE |
| K001160 | Versabond Bone CementLOD · Abbreviated | Smith & Nephew, Inc. | 12/11/2000SE |
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1083-2026 Class II | Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | Heraeus Medical GmbH (Dental Division) | 12/09/2025Open, Classified |
| Z-1082-2026 Class II | Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | Heraeus Medical GmbH (Dental Division) | 12/09/2025Open, Classified |
| Z-1081-2026 Class II | Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | Heraeus Medical GmbH (Dental Division) | 12/09/2025Open, Classified |
| Z-1080-2026 Class II | Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | Heraeus Medical GmbH (Dental Division) | 12/09/2025Open, Classified |
| Z-0737-2023 Class III | Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to…Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language.… | Howmedica Osteonics Corp. | 11/07/2022Open, Classified |
| Z-0736-2023 Class III | Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to…Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language.… | Howmedica Osteonics Corp. | 11/07/2022Open, Classified |
| Z-1649-2021 Class II | 10 GAUGE DRILL, CODE INTVM-DRLProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1648-2021 Class II | 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CCProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1647-2021 Class II | 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15Products labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1646-2021 Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDKProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1645-2021 Class II | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCBProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1644-2021 Class II | 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAKProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1643-2021 Class II | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCDProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1642-2021 Class II | CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMSProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1641-2021 Class II | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDKProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1640-2021 Class II | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCBProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1639-2021 Class II | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAKProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1638-2021 Class II | 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDCProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1637-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBDProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1636-2021 Class II | EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DSProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1635-2021 Class II | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051Products labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1633-2021 Class II | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES…Products labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1632-2021 Class II | RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-USProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1631-2021 Class II | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing systemProducts labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-0933-2021 Class II | VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number:…Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy… | Smith & Nephew, Inc. | 12/18/2020Terminated |
| Z-1250-2018 Class II | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | Stryker Instruments Div. of Stryker… | 11/09/2017Terminated |
| Z-0067-2018 Class II | Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only…Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Encore Medical, Lp | 06/26/2017Open, Classified |
| Z-0066-2018 Class II | Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only…Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Encore Medical, Lp | 06/26/2017Open, Classified |
| Z-0065-2018 Class II | Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET…Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Encore Medical, Lp | 06/26/2017Open, Classified |
| Z-0064-2018 Class II | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET…Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Encore Medical, Lp | 06/26/2017Open, Classified |
| Z-2056-2017 Class II | Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With GentamicinSix complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A… | Zimmer Biomet, Inc. | 04/13/2017Terminated |
| Z-2606-2016 Class II | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate…The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does… | Encore Medical, Lp | 07/26/2016Terminated |
| Z-0900-2015 Class II | Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a…Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek… | Zimmer, Inc. | 12/08/2014Terminated |