510(k) Report

Devices descending from K072636

26 later devices reach A-BSM Bone Substitute Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+1K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+1K090242Gamma-BSM, Beta-BSMEtex Corp.200925—
+2K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+2K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+2K182107CarriGen PFEtex Corporation20181—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K100883CarrigenEtex Corp.20100—
+2K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+2K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K093447CarrigenEtex Corp.201021—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K130392Kinex BioactiveGlobus Medical, Inc.20138—
+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—