510(k) Report

Devices descending from K033138

39 later devices reach CAP3 Bone Substitute Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+1K090242Gamma-BSM, Beta-BSMEtex Corp.200925—
+1K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+1K063050Cap PlusEtex Corp.200734—
+1K072355Ossifuse Bone Substitute MaterialEtex Corp.200726—
+1K062630Ossipro Bone Substitute MaterialEtex Corp.200726—
+2K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+2K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+2K182107CarriGen PFEtex Corporation20181—
+2K132868CarricellEtex Corporation20153—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+2K093447CarrigenEtex Corp.201021—
+2K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+2K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+2K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+2K090310EquivaboneEtex Corp.200928—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K130703Vivorte BVFVivorte, Inc.201311
+3K113049Socket GraftSteiner Laboratories20120—
+3K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+3K100883CarrigenEtex Corp.20100—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K143547Vivorte Trabexus EBVivorte, Inc.201501
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K133678Confirm BioactiveGlobus Medical, Inc.20140—
+5K130977Signify BioactiveGlobus Medical, Inc.20131—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—