Product Code: LOD FDA class 2 21 CFR 888.3027

Bone Cement

Orthopedic

Bone Cement is a polymeric material, typically based on polymethylmethacrylate (PMMA), used in orthopedic and spinal surgery to fix prosthetic implants to bone or to fill bone defects, providing mechanical fixation and load transfer between the implant and the surrounding osseous tissue. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOD, regulated under 21 CFR 888.3027, within the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LOD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LOD
Device Class: FDA class 2
Regulation Number: 888.3027
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 72 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254107	Refobacin Bone Cement R (110034355)	Apr 15, 2026	Substantially Equivalent	Biomet France
K250760	SPECTRUM GV Bone Cement	Apr 02, 2025	Substantially Equivalent	Osteoremedies, LLC
K241674	OSTEOPAL® V	Dec 05, 2024	Substantially Equivalent	Heraeus Medical GmbH
K231556	SPECTRUM® GV Bone Cement	Dec 20, 2023	Substantially Equivalent	Osteoremedies, LLC
K211163	Bone Cement Genta, Bone Cement HV, Bone Cement LV	Jan 09, 2023	Substantially Equivalent	Tecres S.P.A.
K212729	Bone Cement-Normal Viscosity	May 31, 2022	Substantially Equivalent	Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
K211869	OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement	May 19, 2022	Substantially Equivalent	Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
K213812	PALACOS MV pro	Feb 02, 2022	Substantially Equivalent	Heraeus Medical GmbH
K210607	PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro	Jul 09, 2021	Substantially Equivalent	Heraeus Medical GmbH
K202458	BonOs Inject, Pedicle screw kits, Cement pusher	May 18, 2021	Substantially Equivalent	Osartis GmbH
K210125	BonOs HV Genta, BonOs MV Genta, BonOs LV Genta	Mar 19, 2021	Substantially Equivalent	Osartis GmbH
K210120	BonOs HV, BonOs MV, BonOs LV	Mar 19, 2021	Substantially Equivalent	Osartis GmbH
K202475	PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G	Nov 23, 2020	Substantially Equivalent	Heraeus Medical GmbH
K193061	G3 40 Radiopaque Bone Cement	Mar 19, 2020	Substantially Equivalent	G21, S.R.L.
K193059	G1 40 Radiopaque Bone Cement	Mar 19, 2020	Substantially Equivalent	G21, S.R.L.
K192394	Hi-Fatigue Bone Cement	Dec 02, 2019	Substantially Equivalent	Osartis GmbH
K192379	Hi-Fatigue G Bone Cement	Nov 27, 2019	Substantially Equivalent	Osartis GmbH
K190766	PALACOS fast R+G	May 31, 2019	Substantially Equivalent	Heraeus Medical GmbH
K181282	G3A 40 Bone Cement	Jan 09, 2019	Substantially Equivalent	G21, S.R.L.
K182260	PALACOS MV	Sep 17, 2018	Substantially Equivalent	Heraeus Medical GmbH
K173494	OrthoSteady G Bone Cement	Mar 06, 2018	Substantially Equivalent	G21, S.R.L.
K172408	Biomet Bone Cement R	Oct 05, 2017	Substantially Equivalent	Biomet, Inc.
K170802	TRAUMACEM V+ Injectable Bone Cement	Sep 28, 2017	Substantially Equivalent	Synthes (USA) Products, LLC
K171540	Refobacin Bone Cement R	Aug 30, 2017	Substantially Equivalent	Biomet, Inc.
K153737	OSTEOPAL plus	Apr 22, 2016	Substantially Equivalent	Heraeus Medical GmbH
K150408	V-STEADY, V-FAST	Dec 14, 2015	Substantially Equivalent	G21, S.R.L.
K150119	PALACOS R pro	Jun 17, 2015	Substantially Equivalent	Heraeus Medical GmbH
K143134	NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System	Mar 05, 2015	Substantially Equivalent	Cossington, Ltd.
K143100	NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta	Mar 05, 2015	Substantially Equivalent	Cossington, Ltd.
K142157	PALACOS R+G PRO	Sep 05, 2014	Substantially Equivalent	Heraeus Medical GmbH
K123225	BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60	Mar 15, 2013	Substantially Equivalent	Aap Biomaterials GmbH & Co. KG
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	Mar 07, 2013	Substantially Equivalent	Aap Biomaterials GmbH & Co. KG
K092773	CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST	Nov 24, 2009	Substantially Equivalent	Tecres S.P.A.
K092150	COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT	Oct 27, 2009	Substantially Equivalent	Biomet, Inc.
K091608	COBALT MV BONE CEMENT	Sep 17, 2009	Substantially Equivalent	Biomet Manufacturing Corp
K081155	SMARTSET MV BONE CEMENT	May 14, 2008	Substantially Equivalent	DePuy Orthopaedics, Inc.
K070015	COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT	Nov 30, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K062553	SIMPLEX P BONE CEMENT	Jan 08, 2007	Substantially Equivalent	Stryker Orthopaedics
K053198	SIMPLEX P SPEEDSET BONE CEMENT	Jan 26, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K053445	SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT	Jan 06, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K053003	DEPUY CMW 1, 2 AND 3 BONE CEMENTS	Nov 22, 2005	Substantially Equivalent	DePuy Orthopaedics, Inc.
K050085	OSTEOPAL V	Sep 14, 2005	Substantially Equivalent	Heraeus Kulzer,GmbH
K051496	COBALT BONE CEMENT	Aug 04, 2005	Substantially Equivalent	Biomet, Inc.
K051532	COBALT G HV BONE CEMENT	Aug 03, 2005	Substantially Equivalent	Biomet, Inc.
K050855	PALAMED G	Jul 07, 2005	Substantially Equivalent	Heraeus Kulzer,GmbH
K050854	PALACOS LV+G	Jul 07, 2005	Substantially Equivalent	Heraeus Kulzer,GmbH
K043403	CEMEX SYSTEM GENTA FAST BONE CEMENT	Dec 28, 2004	Substantially Equivalent	Exactech, Inc.
K041656	MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT	Jul 01, 2004	Substantially Equivalent	DePuy Orthopaedics, Inc.
K032945	SIMPLEX X	May 25, 2004	Substantially Equivalent	Stryker Corp.
K031673	REFOBACIN -PALACOS G	May 25, 2004	Substantially Equivalent	Heraeus Kulzer GmbH & Co. KG
K033596	CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT	May 10, 2004	Substantially Equivalent	Exactech, Inc.
K022688	VERSABOND AB BONE CEMENT	Apr 29, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K033563	SMARTSET GHV GENTAMICIN BONE CEMENT	Feb 05, 2004	Substantially Equivalent	DePuy Orthopaedics, Inc.
K033382	SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT	Feb 05, 2004	Substantially Equivalent	DePuy Orthopaedics, Inc.
K030086	PALACOS R BONE CEMENT WITH GENTAMICIN	Dec 17, 2003	Substantially Equivalent	Biomet, Inc.
K033509	MODIFICATION TO VERSABOND BONE CEMENT	Nov 28, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K023103	DEPUY 1 GENTAMICIN BONE CEMENT	Sep 29, 2003	Substantially Equivalent	DePuy Orthopaedics, Inc.
K030904	PALAMED	Sep 23, 2003	Substantially Equivalent	Heraeus Medical GmbH Technology
K030903	OSTEOPAL	Sep 23, 2003	Substantially Equivalent	Heraeus Kulzer GmbH & Co. KG
K030902	PALACOS R	Sep 23, 2003	Substantially Equivalent	Heraeus Kulzer GmbH & Co. KG
K031430	CEMEX SYSTEM FAST	May 22, 2003	Substantially Equivalent	Exactech, Inc.
K014199	SURGICAL SIMPLEX P WITH TOBRAMYCIN	May 06, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K022251	PALABOND	Feb 26, 2003	Substantially Equivalent	Heraeus Kulzer GmbH & Co. KG
K023012	SMARTSET HV BONE CEMENT	Feb 13, 2003	Substantially Equivalent	DePuy Orthopaedics, Inc.
K021499	CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT	Jul 24, 2002	Substantially Equivalent	DePuy Orthopaedics, Inc.
K021715	CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL	Jun 12, 2002	Substantially Equivalent	Exactech, Inc.
K013755	CONCERT RADIOPAQUE BONE CEMENT	Feb 08, 2002	Substantially Equivalent	Immedica, Inc.
K993836	GENERATION 4 BONE CEMENT	Dec 19, 2001	Substantially Equivalent	Biomet, Inc.
K010586	PALAMED BONE CEMENT	Oct 30, 2001	Substantially Equivalent	Merck Biomaterial GmbH
K000943	CEMEX SYSTEM GUN APPLICATION VERSION	Feb 08, 2001	Substantially Equivalent	Exactech, Inc.
K002652	SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII	Jan 26, 2001	Substantially Equivalent	Stryker Corp.
K001160	VERSABOND BONE CEMENT	Dec 11, 2000	Substantially Equivalent	Smith & Nephew, Inc.