510(k) Report

Devices descending from P810020

104 later devices reach Palacos R Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051496Cobalt Bone CementBiomet, Inc.200534
+1K050855Palamed GHeraeus Kulzer,GmbH20054—
+1K031673Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG2004151
+1K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+1K030086Palacos R Bone Cement with GentamicinBiomet, Inc.200325—
+1K030903OsteopalHeraeus Kulzer GmbH & Co. KG200340—
+1K030902Palacos RHeraeus Kulzer GmbH & Co. KG200313—
+1K022251PalabondHeraeus Kulzer GmbH & Co. KG20030—
+1K023012Smartset HV Bone CementDePuy Orthopaedics, Inc.200312—
+2K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH20210—
+2K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH20210—
+2K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH20203—
+2K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200—
+2K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200—
+2K192394Hi-Fatigue Bone CementOsartis GmbH20190—
+2K192379Hi-Fatigue G Bone CementOsartis GmbH20190—
+2K190766PALACOS fast R+GHeraeus Medical GmbH20190—
+2K173494OrthoSteady G Bone CementG21, S.R.L.20182—
+2K172408Biomet Bone Cement RBiomet, Inc.20170—
+2K171540Refobacin Bone Cement RBiomet, Inc.20171—
+2K150850Refobacin Bone Cement RBiomet, Inc.20150—
+2K150119PALACOS R proHeraeus Medical GmbH20154—
+2K142157Palacos R+G ProHeraeus Medical GmbH20144—
+2K123225Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60Aap Biomaterials GmbH & Co. KG20130—
+2K123081Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40…Aap Biomaterials GmbH & Co. KG201301
+2K091608Cobalt MV Bone CementBiomet Manufacturing Corp200912
+2K081155Smartset MV Bone CementDePuy Orthopaedics, Inc.20081—
+2K070015Cobalt V Radiopaque Vertebroplasty Bone CementBiomet Manufacturing Corp20070—
+2K053198Simplex P Speedset Bone CementHowmedica Osteonics Corp.20061—
+2K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.20060—
+2K050085Osteopal VHeraeus Kulzer,GmbH200538—
+2K051532Cobalt G HV Bone CementBiomet, Inc.200523—
+2K050854Palacos LV+GHeraeus Kulzer,GmbH20050—
+2K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.200491
+3K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC20260—
+3K254107Refobacin Bone Cement R (110034355)Biomet France20260—
+3K241674Osteopal® VHeraeus Medical GmbH20240—
+3K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE20220—
+3K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH202116
+3K153737OSTEOPAL plusHeraeus Medical GmbH20160—
+3K150408V-Steady, V-FastG21, S.R.L.201528—
+3K092150Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone CementBiomet, Inc.20091—
+3K090460Bonos InjectAap Biomaterials GmbH20098—
+3K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A.200820—
+3K081163Smartset GMV Gentamicin Bone CementDePuy Orthopaedics, Inc.20080—
+3K063857Simplex P Speedset with Tobramycin Bone CementHowmedica Osteonics Corp.20070—
+3K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc.20060—
+3K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc.20048—
+4K213812PALACOS MV proHeraeus Medical GmbH202202
+4K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K121876Vertecem II Cement KitAap Biomaterials GmbH20120—
+4K101356Spacer-G and Spacer-KTecres S.P.A.201119—
+4K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.20054—
+4K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH20191—
+5K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+5K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC201216—
+6K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+6K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K220492COPAL exchange G hip spacerHeraeus Medical GmbH20220—
+6K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+6K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC20195—
+6K190216SpaceFlex KneeG21, S.R.L.20191—
+6K173967Remedy Acetabular CupOsteoremedies, LLC20185—
+7K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+7K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC20240—
+7K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC20231—
+7K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+7K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—