ClearanceBrief
Panels › Orthopedic › Product code LOD · Class 2

Bone Cement

Regulation 888.3027

1510(k)s in 12 months (72 all time)
6recalls in 12 months (36 all time)
16recalls that name a 510(k)
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Top companies in LOD

Company510(k)sRecalls
BIOPSYBELL S.R.L.018
DePuy Orthopaedics, Inc.90
Heraeus Medical GmbH90
Biomet, Inc.71
Heraeus Kulzer GmbH & Co. KG70
Heraeus Medical GmbH (Dental Division)06
Encore Medical, Lp05
Exactech, Inc.50
G21, S.R.L.50
Osartis GmbH50
Decided510(k)Device and applicantCode
Apr 15, 2026K254107Refobacin Bone Cement R (110034355)
Biomet France, FR
LOD
Apr 2, 2025K250760SPECTRUM GV Bone Cement
Osteoremedies, LLC
LOD
Dec 5, 2024K241674OSTEOPAL® V
Heraeus Medical GmbH, DE
LOD
Dec 20, 2023K231556SPECTRUM® GV Bone Cement
Osteoremedies, LLC
LOD
Jan 9, 2023K211163Bone Cement Genta, Bone Cement HV, Bone Cement LV
Tecres S.P.A., IT
LOD
May 31, 2022K212729Bone Cement-Normal Viscosity
Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda, BR
LOD
May 19, 2022K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE, TR
LOD
Feb 2, 2022K213812PALACOS MV pro
Heraeus Medical GmbH, DE
LOD
Jul 9, 2021K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
Heraeus Medical GmbH, DE
LOD
May 18, 2021K202458BonOs Inject, Pedicle screw kits, Cement pusher
Osartis GmbH, DE
LOD
Mar 19, 2021K210125BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
Osartis GmbH, DE
LOD
Mar 19, 2021K210120BonOs HV, BonOs MV, BonOs LV
Osartis GmbH, DE
LOD
Nov 23, 2020K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
Heraeus Medical GmbH, DE
LOD
Mar 19, 2020K193061G3 40 Radiopaque Bone Cement
G21, S.R.L., IT
LOD
Mar 19, 2020K193059G1 40 Radiopaque Bone Cement
G21, S.R.L., IT
LOD
Dec 2, 2019K192394Hi-Fatigue Bone Cement
Osartis GmbH, DE
LOD
Nov 27, 2019K192379Hi-Fatigue G Bone Cement
Osartis GmbH, DE
LOD
May 31, 2019K190766PALACOS fast R+G
Heraeus Medical GmbH, DE
LOD
Jan 9, 2019K181282G3A 40 Bone Cement
G21, S.R.L., IT
LOD
Sep 17, 2018K182260PALACOS MV
Heraeus Medical GmbH, DE
LOD
Mar 6, 2018K173494OrthoSteady G Bone Cement
G21, S.R.L., IT
LOD
Oct 5, 2017K172408Biomet Bone Cement R
Biomet, Inc.
LOD
Sep 28, 2017K170802TRAUMACEM™ V+ Injectable Bone Cement
Synthes (USA) Products, LLC
LOD
Aug 30, 2017K171540Refobacin Bone Cement R
Biomet, Inc.
LOD
Apr 22, 2016K153737OSTEOPAL plus
Heraeus Medical GmbH, DE
LOD
Dec 14, 2015K150408V-STEADY, V-FAST
G21, S.R.L., IT
LOD
Jun 17, 2015K150119PALACOS R pro
Heraeus Medical GmbH, DE
LOD
Mar 5, 2015K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System
Cossington, Ltd., GB
LOD
Mar 5, 2015K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta
Cossington, Ltd., GB
LOD
Sep 5, 2014K142157PALACOS R+G PRO
Heraeus Medical GmbH, DE
LOD
Mar 15, 2013K123225BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
Aap Biomaterials GmbH & Co. KG, DE
LOD
Mar 7, 2013K123081BONOS 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, DE
LOD
Nov 24, 2009K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
Tecres S.P.A.
LOD
Oct 27, 2009K092150COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
Biomet, Inc.
LOD
Sep 17, 2009K091608COBALT MV BONE CEMENT
Biomet Manufacturing Corp
LOD
May 14, 2008K081155SMARTSET MV BONE CEMENT
DePuy Orthopaedics, Inc.
LOD
Nov 30, 2007K070015COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
Biomet Manufacturing Corp
LOD
Jan 8, 2007K062553SIMPLEX P BONE CEMENT
Stryker Orthopaedics
LOD
Jan 26, 2006K053198SIMPLEX P SPEEDSET BONE CEMENT
Howmedica Osteonics Corp.
LOD
Jan 6, 2006K053445SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
DePuy Orthopaedics, Inc.
LOD
Nov 22, 2005K053003DEPUY CMW 1, 2 AND 3 BONE CEMENTS
DePuy Orthopaedics, Inc.
LOD
Sep 14, 2005K050085OSTEOPAL V
Heraeus Kulzer,GmbH, DE
LOD
Aug 4, 2005K051496COBALT BONE CEMENT
Biomet, Inc.
LOD
Aug 3, 2005K051532COBALT G HV BONE CEMENT
Biomet, Inc.
LOD
Jul 7, 2005K050855PALAMED G
Heraeus Kulzer,GmbH, DE
LOD
Jul 7, 2005K050854PALACOS LV+G
Heraeus Kulzer,GmbH, DE
LOD
Dec 28, 2004K043403CEMEX SYSTEM GENTA FAST BONE CEMENT
Exactech, Inc.
LOD
Jul 1, 2004K041656MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
DePuy Orthopaedics, Inc.
LOD
May 25, 2004K032945SIMPLEX X
Stryker Corp.
LOD
May 25, 2004K031673REFOBACIN -PALACOS G
Heraeus Kulzer GmbH & Co. KG, DE
LOD

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