510(k) Report

Devices descending from K041168

55 later devices reach Allomatrix Putty through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)20250—
+1K091912B-Genin and R-GeninBerkeley Advanced Biomaterials, Inc.20101—
+1K071849Allofuse Gel and PuttyAllosource, Inc.200811
+1K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+1K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069—
+1K043209Viagraf DBM PasteOsteotech, Inc.20050—
+1K053098Optium DBM Gel and PuttyLifenet200539—
+1K043048Grafton Plus DBM PasteOsteotech, Inc.20051015
+1K052913Ignite Bone Void Filler KitWrightmedicaltechnologyinc20051—
+2K242799PliaFX FloLifenet Health20240—
+2K190482IGNITE Bone Void FillerWrightmedicaltechnologyinc20190—
+2K132868CarricellEtex Corporation20153—
+2K113791B-Genin, R-GeninBerkeley Advanced Biomaterials, Inc.20120—
+2K103036Allofuse PlusAllosource, Inc.20110—
+2K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+2K082002Progenix PlusMedtronic Sofamor Danek20080—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+2K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+2K063050Cap PlusEtex Corp.200734—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+3K090310EquivaboneEtex Corp.200928—
+3K082463ProgenixMedtronic Sofamor Danek20080—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K130703Vivorte BVFVivorte, Inc.201311
+4K113049Socket GraftSteiner Laboratories20120—
+4K100883CarrigenEtex Corp.20100—
+4K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+4K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+4K093447CarrigenEtex Corp.201021—
+5K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+5K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+5K182107CarriGen PFEtex Corporation20181—
+5K143547Vivorte Trabexus EBVivorte, Inc.201501
+5K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+6K130392Kinex BioactiveGlobus Medical, Inc.20138—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—
+7K173008SCS 17-01Anika Therapeutics, Inc.20174—
+7K133678Confirm BioactiveGlobus Medical, Inc.20140—
+7K130977Signify BioactiveGlobus Medical, Inc.20131—
+8K223915TactosetAnika Therapeutics, Inc.20231—
+8K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+8K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+8K190956SCS 17-01Anika Therapeutics, Inc.20203—
+9K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—