510(k) Report

Devices descending from K000122

253 later devices reach Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+5K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+5K130703Vivorte BVFVivorte, Inc.201311
+5K113049Socket GraftSteiner Laboratories20120—
+5K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+5K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+5K100883CarrigenEtex Corp.20100—
+5K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+5K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+5K093447CarrigenEtex Corp.201021—
+5K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+5K090387Kainos+Signus Medizintechnik GmbH20090—
+5K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+5K082002Progenix PlusMedtronic Sofamor Danek20080—
+5K082463ProgenixMedtronic Sofamor Danek20080—
+5K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+5K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+6K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+6K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+6K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+6K182107CarriGen PFEtex Corporation20181—
+6K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+6K143547Vivorte Trabexus EBVivorte, Inc.201501
+6K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+6K102528N-Force Fixation SystemInnovision, Inc.20115—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+7K151146N-Force Fixation SystemInnovision, Inc.20151—
+7K142776Flow-ScrewFlow-Fx, LLC20151—
+7K132244N-Force Fixation SystemInnovision, Inc.20143—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—