510(k) Report

Devices descending from K043420

87 later devices reach Osteofil, Optefil, Regenafil, Rti Allograft Paste through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091912B-Genin and R-GeninBerkeley Advanced Biomaterials, Inc.20101—
+1K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV20075—
+1K062459Origen DBM with Bioactive GlassNanotherapeutics200756—
+1K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069—
+1K051047Colloss E Bone Void FillerOssacur AG20060—
+1K050806OptecureExactech, Inc.20063—
+1K053098Optium DBM Gel and PuttyLifenet200539—
+1K050690ConnexusIsotis Orthobiologics, Inc.20056—
+2K242799PliaFX FloLifenet Health20240—
+2K132868CarricellEtex Corporation20153—
+2K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+2K120279Nanofuse DBMNanotherapeutics20122—
+2K113791B-Genin, R-GeninBerkeley Advanced Biomaterials, Inc.20120—
+2K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc.201132
+2K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences20110—
+2K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+2K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+2K081817Accell TBM-RIsotis Orthobiologics, Inc.20080—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+2K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+2K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+2K063050Cap PlusEtex Corp.200734—
+2K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+2K061668Optecure +CCCExactech, Inc.20062—
+2K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc.20050—
+3K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+3K212135Dry DBM- A PuttySeaspine Corporation20211—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+3K142104Nanofuse DBMNanotherapeutics, Inc.20151—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+3K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+3K090310EquivaboneEtex Corp.200928—
+3K082002Progenix PlusMedtronic Sofamor Danek20080—
+3K082463ProgenixMedtronic Sofamor Danek20080—
+3K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+3K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K240450Citrepore™Acuitive Technologies, Inc.20240—
+4K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEAmend Surgical, Inc.20170—
+4K141207Novabone Bioactive StripNovabone Products, LLC20140—
+4K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+4K130703Vivorte BVFVivorte, Inc.201311
+4K113049Socket GraftSteiner Laboratories20120—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+4K100883CarrigenEtex Corp.20100—
+4K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+4K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+4K093447CarrigenEtex Corp.201021—
+4K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+4K090387Kainos+Signus Medizintechnik GmbH20090—
+5K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+5K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+5K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+5K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+5K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+5K182107CarriGen PFEtex Corporation20181—
+5K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+5K143547Vivorte Trabexus EBVivorte, Inc.201501
+5K133678Confirm BioactiveGlobus Medical, Inc.20140—
+5K130392Kinex BioactiveGlobus Medical, Inc.20138—
+5K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+6K173008SCS 17-01Anika Therapeutics, Inc.20174—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+6K130977Signify BioactiveGlobus Medical, Inc.20131—
+7K223915TactosetAnika Therapeutics, Inc.20231—
+7K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+7K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+7K190956SCS 17-01Anika Therapeutics, Inc.20203—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—