510(k) Report

Devices descending from K030288

33 later devices reach Polygraft Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073303Norian DrillableSynthes (Usa)200813
+1K062691ComporusTakiron Co., Ltd.20080—
+1K062607Polygraft BGSSmith & Nephew, Inc.20070—
+1K060285Bonegen - TRBio-Lok Intl., Inc.20061—
+1K040047Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc.2004231
+1K033707Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX…Osteobiologics, Inc.200410—
+2K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+2K102208NanogenOrthogen, LLC20110—
+2K102722Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC201104
+2K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+2K063346Pro Osteon 500REbi, L.P.20070—
+2K063359INQUIsto Technologies, Inc.200713—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+3K170165Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.20170—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K111838Inqu Paste MixIsto Technologies, Inc.20110—
+3K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+3K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+3K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+3K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+3K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+3K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+3K071428INQUIsto Technologies, Inc.200711—
+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—