510(k) Report

Devices descending from K053098

39 later devices reach Optium DBM Gel and Putty through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242799PliaFX FloLifenet Health20240—
+1K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+1K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+1K063050Cap PlusEtex Corp.200734—
+2K132868CarricellEtex Corporation20153—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+2K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+2K090310EquivaboneEtex Corp.200928—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K130703Vivorte BVFVivorte, Inc.201311
+3K113049Socket GraftSteiner Laboratories20120—
+3K100883CarrigenEtex Corp.20100—
+3K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+3K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+3K093447CarrigenEtex Corp.201021—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+4K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+4K182107CarriGen PFEtex Corporation20181—
+4K143547Vivorte Trabexus EBVivorte, Inc.201501
+4K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+4K102528N-Force Fixation SystemInnovision, Inc.20115—
+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—