510(k) Report

Devices descending from K031399

69 later devices reach Intergro DBM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+1K063050Cap PlusEtex Corp.200734—
+1K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV20075—
+1K051047Colloss E Bone Void FillerOssacur AG20060—
+1K050690ConnexusIsotis Orthobiologics, Inc.20056—
+1K040419Dynagraft IIIsotis Orthobiologics, Inc.200528—
+2K173424BioSphere FlexSynergy Biomedical20180—
+2K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+2K132868CarricellEtex Corporation20153—
+2K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+2K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp.20124—
+2K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences20110—
+2K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+2K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+2K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+2K090310EquivaboneEtex Corp.200928—
+2K071849Allofuse Gel and PuttyAllosource, Inc.200811
+2K081817Accell TBM-RIsotis Orthobiologics, Inc.20080—
+2K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+2K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+2K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc.20071—
+2K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc.20058—
+2K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc.20050—
+3K212135Dry DBM- A PuttySeaspine Corporation20211—
+3K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation20180—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K152077MaxiGenHans Biomed Corp.20160—
+3K151271BellaFuseHans Biomed Corp.20160—
+3K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.20140—
+3K130703Vivorte BVFVivorte, Inc.201311
+3K113049Socket GraftSteiner Laboratories20120—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K103036Allofuse PlusAllosource, Inc.20110—
+3K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+3K093447CarrigenEtex Corp.201021—
+3K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+3K082002Progenix PlusMedtronic Sofamor Danek20080—
+3K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+3K061668Optecure +CCCExactech, Inc.20062—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+4K182107CarriGen PFEtex Corporation20181—
+4K143547Vivorte Trabexus EBVivorte, Inc.201501
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+4K102528N-Force Fixation SystemInnovision, Inc.20115—
+4K100883CarrigenEtex Corp.20100—
+4K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+4K082463ProgenixMedtronic Sofamor Danek20080—
+4K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+5K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+5K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+5K151146N-Force Fixation SystemInnovision, Inc.20151—
+5K142776Flow-ScrewFlow-Fx, LLC20151—
+5K132244N-Force Fixation SystemInnovision, Inc.20143—
+5K130392Kinex BioactiveGlobus Medical, Inc.20138—
+6K173556Injection ScrewBiedermann Medtech, Inc.20180—
+6K173008SCS 17-01Anika Therapeutics, Inc.20174—
+6K133678Confirm BioactiveGlobus Medical, Inc.20140—
+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—
+8K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—