Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Bone Cement

FDA product code LOD · 67 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3027
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2000-12-11 – 2026-04-15

LOD 2026-04-15

Refobacin Bone Cement R (110034355)

Applicant Biomet France

K number K254107

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LOD 2025-04-02

SPECTRUM GV Bone Cement

Applicant Osteoremedies, LLC

K number K250760

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LOD 2024-12-05

OSTEOPAL® V

Applicant Heraeus Medical GmbH

K number K241674

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LOD 2023-12-20

SPECTRUM® GV Bone Cement

Applicant Osteoremedies, LLC

K number K231556

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LOD 2023-01-09

Bone Cement Genta, Bone Cement HV, Bone Cement LV

Applicant Tecres S.P.A.

K number K211163

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LOD 2022-05-31

Bone Cement-Normal Viscosity

Applicant Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda

K number K212729

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LOD 2022-05-19

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

Applicant Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE

K number K211869

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LOD 2022-02-02

PALACOS MV pro

Applicant Heraeus Medical GmbH

K number K213812

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LOD 2021-07-09

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

Applicant Heraeus Medical GmbH

K number K210607

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LOD 2021-05-18

BonOs Inject, Pedicle screw kits, Cement pusher

Applicant Osartis GmbH

K number K202458

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LOD 2021-03-19

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

Applicant Osartis GmbH

K number K210125

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LOD 2021-03-19

BonOs HV, BonOs MV, BonOs LV

Applicant Osartis GmbH

K number K210120

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LOD 2020-11-23

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

Applicant Heraeus Medical GmbH

K number K202475

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LOD 2020-03-19

G3 40 Radiopaque Bone Cement

Applicant G21, S.R.L.

K number K193061

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LOD 2020-03-19

G1 40 Radiopaque Bone Cement

Applicant G21, S.R.L.

K number K193059

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LOD 2019-12-02

Hi-Fatigue Bone Cement

Applicant Osartis GmbH

K number K192394

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LOD 2019-11-27

Hi-Fatigue G Bone Cement

Applicant Osartis GmbH

K number K192379

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LOD 2019-05-31

PALACOS fast R+G

Applicant Heraeus Medical GmbH

K number K190766

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LOD 2019-01-09

G3A 40 Bone Cement

Applicant G21, S.R.L.

K number K181282

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LOD 2018-09-17

PALACOS MV

Applicant Heraeus Medical GmbH

K number K182260

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LOD 2018-03-06

OrthoSteady G Bone Cement

Applicant G21, S.R.L.

K number K173494

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LOD 2017-10-05

Biomet Bone Cement R

Applicant Biomet, Inc.

K number K172408

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LOD 2017-09-28

TRAUMACEM™ V+ Injectable Bone Cement

Applicant Synthes (USA) Products, LLC

K number K170802

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LOD 2017-08-30

Refobacin Bone Cement R

Applicant Biomet, Inc.

K number K171540

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LOD 2016-04-22

OSTEOPAL plus

Applicant Heraeus Medical GmbH

K number K153737

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LOD 2013-03-15

BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60

Applicant Aap Biomaterials GmbH & Co. KG

K number K123225

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LOD 2013-03-07

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

Applicant Aap Biomaterials GmbH & Co. KG

K number K123081

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LOD 2009-11-24

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST

Applicant Tecres S.P.A.

K number K092773

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LOD 2009-10-27

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

Applicant Biomet, Inc.

K number K092150

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LOD 2009-09-17

COBALT MV BONE CEMENT

Applicant Biomet Manufacturing Corp

K number K091608

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LOD 2008-05-14

SMARTSET MV BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K081155

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LOD 2007-11-30

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT

Applicant Biomet Manufacturing Corp

K number K070015

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LOD 2007-01-08

SIMPLEX P BONE CEMENT

Applicant Stryker Orthopaedics

K number K062553

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LOD 2006-01-26

SIMPLEX P SPEEDSET BONE CEMENT

Applicant Howmedica Osteonics Corp.

K number K053198

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LOD 2006-01-06

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K053445

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LOD 2005-11-22

DEPUY CMW 1, 2 AND 3 BONE CEMENTS

Applicant DePuy Orthopaedics, Inc.

K number K053003

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LOD 2005-09-14

OSTEOPAL V

Applicant Heraeus Kulzer,GmbH

K number K050085

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LOD 2005-08-04

COBALT BONE CEMENT

Applicant Biomet, Inc.

K number K051496

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LOD 2005-08-03

COBALT G HV BONE CEMENT

Applicant Biomet, Inc.

K number K051532

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LOD 2005-07-07

PALAMED G

Applicant Heraeus Kulzer,GmbH

K number K050855

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LOD 2005-07-07

PALACOS LV+G

Applicant Heraeus Kulzer,GmbH

K number K050854

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LOD 2004-12-28

CEMEX SYSTEM GENTA FAST BONE CEMENT

Applicant Exactech, Inc.

K number K043403

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LOD 2004-07-01

MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K041656

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LOD 2004-05-25

SIMPLEX X

Applicant Stryker Corp.

K number K032945

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LOD 2004-05-25

REFOBACIN -PALACOS G

Applicant Heraeus Kulzer GmbH & Co. KG

K number K031673

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LOD 2004-05-10

CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT

Applicant Exactech, Inc.

K number K033596

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LOD 2004-04-29

VERSABOND AB BONE CEMENT

Applicant Smith & Nephew, Inc.

K number K022688

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LOD 2004-02-05

SMARTSET GHV GENTAMICIN BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K033563

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LOD 2004-02-05

SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K033382

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LOD 2003-12-17

PALACOS R BONE CEMENT WITH GENTAMICIN

Applicant Biomet, Inc.

K number K030086

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LOD 2003-11-28

MODIFICATION TO VERSABOND BONE CEMENT

Applicant Smith & Nephew, Inc.

K number K033509

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LOD 2003-09-29

DEPUY 1 GENTAMICIN BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K023103

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LOD 2003-09-23

PALAMED

Applicant Heraeus Medical GmbH Technology

K number K030904

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LOD 2003-09-23

OSTEOPAL

Applicant Heraeus Kulzer GmbH & Co. KG

K number K030903

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LOD 2003-09-23

PALACOS R

Applicant Heraeus Kulzer GmbH & Co. KG

K number K030902

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LOD 2003-05-22

CEMEX SYSTEM FAST

Applicant Exactech, Inc.

K number K031430

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LOD 2003-05-06

SURGICAL SIMPLEX P WITH TOBRAMYCIN

Applicant Howmedica Osteonics Corp.

K number K014199

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LOD 2003-02-26

PALABOND

Applicant Heraeus Kulzer GmbH & Co. KG

K number K022251

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LOD 2003-02-13

SMARTSET HV BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K023012

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LOD 2002-07-24

CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT

Applicant DePuy Orthopaedics, Inc.

K number K021499

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LOD 2002-06-12

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL

Applicant Exactech, Inc.

K number K021715

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LOD 2002-02-08

CONCERT RADIOPAQUE BONE CEMENT

Applicant Immedica, Inc.

K number K013755

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LOD 2001-12-19

GENERATION 4 BONE CEMENT

Applicant Biomet, Inc.

K number K993836

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LOD 2001-10-30

PALAMED BONE CEMENT

Applicant Merck Biomaterial GmbH

K number K010586

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LOD 2001-02-08

CEMEX SYSTEM GUN APPLICATION VERSION

Applicant Exactech, Inc.

K number K000943

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LOD 2001-01-26

SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII

Applicant Stryker Corp.

K number K002652

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LOD 2000-12-11

VERSABOND BONE CEMENT

Applicant Smith & Nephew, Inc.

K number K001160

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