510(k) Report

Devices descending from K040047

23 later devices reach Polygraft BGS; Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+1K063346Pro Osteon 500REbi, L.P.20070—
+1K063359INQUIsto Technologies, Inc.200713—
+1K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+2K170165Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.20170—
+2K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+2K111838Inqu Paste MixIsto Technologies, Inc.20110—
+2K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+2K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+2K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+2K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+2K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+2K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+2K071428INQUIsto Technologies, Inc.200711—
+3K130392Kinex BioactiveGlobus Medical, Inc.20138—
+4K173008SCS 17-01Anika Therapeutics, Inc.20174—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K130977Signify BioactiveGlobus Medical, Inc.20131—
+5K223915TactosetAnika Therapeutics, Inc.20231—
+5K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+5K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—