Atlas FDA

LOD

72 FDA 510(k) clearances · Product code

128 daysmedian time to decision
337 days90th percentile
72clearances measured

FDA profile

Official device name
Bone Cement
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 782 · 2022: 472 · 2023: 475 · 2024: 491 · 2025: 360 · 2026: 153
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Refobacin Bone Cement R (110034355) (K254107)Biomet France2026-04-15
SPECTRUM GV Bone Cement (K250760)Osteoremedies, LLC2025-04-02
OSTEOPAL® V (K241674)Heraeus Medical GmbH2024-12-05
SPECTRUM® GV Bone Cement (K231556)Osteoremedies, LLC2023-12-20
Bone Cement Genta, Bone Cement HV, Bone Cement LV (K211163)Tecres S.P.A.2023-01-09
Bone Cement-Normal Viscosity (K212729)Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda2022-05-31
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (K211869)Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022-05-19
PALACOS MV pro (K213812)Heraeus Medical GmbH2022-02-02
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (K210607)Heraeus Medical GmbH2021-07-09
BonOs Inject, Pedicle screw kits, Cement pusher (K202458)Osartis GmbH2021-05-18
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (K210125)Osartis GmbH2021-03-19
BonOs HV, BonOs MV, BonOs LV (K210120)Osartis GmbH2021-03-19
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (K202475)Heraeus Medical GmbH2020-11-23
G3 40 Radiopaque Bone Cement (K193061)G21, S.R.L.2020-03-19
G1 40 Radiopaque Bone Cement (K193059)G21, S.R.L.2020-03-19
Hi-Fatigue Bone Cement (K192394)Osartis GmbH2019-12-02
Hi-Fatigue G Bone Cement (K192379)Osartis GmbH2019-11-27
PALACOS fast R+G (K190766)Heraeus Medical GmbH2019-05-31
G3A 40 Bone Cement (K181282)G21, S.R.L.2019-01-09
PALACOS MV (K182260)Heraeus Medical GmbH2018-09-17
OrthoSteady G Bone Cement (K173494)G21, S.R.L.2018-03-06
Biomet Bone Cement R (K172408)Biomet, Inc.2017-10-05
TRAUMACEM™ V+ Injectable Bone Cement (K170802)Synthes (USA) Products, LLC2017-09-28
Refobacin Bone Cement R (K171540)Biomet, Inc.2017-08-30
OSTEOPAL plus (K153737)Heraeus Medical GmbH2016-04-22
V-STEADY, V-FAST (K150408)G21, S.R.L.2015-12-14
PALACOS R pro (K150119)Heraeus Medical GmbH2015-06-17
NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System (K143134)Cossington, Ltd.2015-03-05
NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta (K143100)Cossington, Ltd.2015-03-05
PALACOS R+G PRO (K142157)Heraeus Medical GmbH2014-09-05
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 (K123225)Aap Biomaterials GmbH & Co. KG2013-03-15
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 (K123081)Aap Biomaterials GmbH & Co. KG2013-03-07
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (K092773)Tecres S.P.A.2009-11-24
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT (K092150)Biomet, Inc.2009-10-27
COBALT MV BONE CEMENT (K091608)Biomet Manufacturing Corp2009-09-17
SMARTSET MV BONE CEMENT (K081155)DePuy Orthopaedics, Inc.2008-05-14
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT (K070015)Biomet Manufacturing Corp2007-11-30
SIMPLEX P BONE CEMENT (K062553)Stryker Orthopaedics2007-01-08
SIMPLEX P SPEEDSET BONE CEMENT (K053198)Howmedica Osteonics Corp.2006-01-26
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT (K053445)DePuy Orthopaedics, Inc.2006-01-06
DEPUY CMW 1, 2 AND 3 BONE CEMENTS (K053003)DePuy Orthopaedics, Inc.2005-11-22
OSTEOPAL V (K050085)Heraeus Kulzer,GmbH2005-09-14
COBALT BONE CEMENT (K051496)Biomet, Inc.2005-08-04
COBALT G HV BONE CEMENT (K051532)Biomet, Inc.2005-08-03
PALACOS LV+G (K050854)Heraeus Kulzer,GmbH2005-07-07
PALAMED G (K050855)Heraeus Kulzer,GmbH2005-07-07
CEMEX SYSTEM GENTA FAST BONE CEMENT (K043403)Exactech, Inc.2004-12-28
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT (K041656)DePuy Orthopaedics, Inc.2004-07-01
REFOBACIN -PALACOS G (K031673)Heraeus Kulzer GmbH & Co. KG2004-05-25
SIMPLEX X (K032945)Stryker Corp.2004-05-25
CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT (K033596)Exactech, Inc.2004-05-10
VERSABOND AB BONE CEMENT (K022688)Smith & Nephew, Inc.2004-04-29
SMARTSET GHV GENTAMICIN BONE CEMENT (K033563)DePuy Orthopaedics, Inc.2004-02-05
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT (K033382)DePuy Orthopaedics, Inc.2004-02-05
PALACOS R BONE CEMENT WITH GENTAMICIN (K030086)Biomet, Inc.2003-12-17
MODIFICATION TO VERSABOND BONE CEMENT (K033509)Smith & Nephew, Inc.2003-11-28
DEPUY 1 GENTAMICIN BONE CEMENT (K023103)DePuy Orthopaedics, Inc.2003-09-29
PALACOS R (K030902)Heraeus Kulzer GmbH & Co. KG2003-09-23
OSTEOPAL (K030903)Heraeus Kulzer GmbH & Co. KG2003-09-23
PALAMED (K030904)Heraeus Medical GmbH Technology2003-09-23
CEMEX SYSTEM FAST (K031430)Exactech, Inc.2003-05-22
SURGICAL SIMPLEX P WITH TOBRAMYCIN (K014199)Howmedica Osteonics Corp.2003-05-06
PALABOND (K022251)Heraeus Kulzer GmbH & Co. KG2003-02-26
SMARTSET HV BONE CEMENT (K023012)DePuy Orthopaedics, Inc.2003-02-13
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT (K021499)DePuy Orthopaedics, Inc.2002-07-24
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL (K021715)Exactech, Inc.2002-06-12
CONCERT RADIOPAQUE BONE CEMENT (K013755)Immedica, Inc.2002-02-08
GENERATION 4 BONE CEMENT (K993836)Biomet, Inc.2001-12-19
PALAMED BONE CEMENT (K010586)Merck Biomaterial GmbH2001-10-30
CEMEX SYSTEM GUN APPLICATION VERSION (K000943)Exactech, Inc.2001-02-08
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII (K002652)Stryker Corp.2001-01-26
VERSABOND BONE CEMENT (K001160)Smith & Nephew, Inc.2000-12-11

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Every clearance here is in the API, with alerts when new ones post.