510(k) Report

Devices descending from K043133

43 later devices reach Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080507Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical ImplantCeremed, Inc.20089—
+1K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc.200638—
+2K111323Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc.20112—
+2K111538Skaffold CisSkeletal Kinetics, LLC201118—
+2K081531Aoc Soluble Implant MaterialCeremed, Inc.20085—
+2K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc.200729—
+3K142348OsteoSeal Bone HemostatHemostasis, LLC20150—
+3K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201413—
+3K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141—
+3K123243Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc.201316—
+3K120220Adaptain Soluble Implant MaterialCeremed, Inc.20122—
+3K103047Ceretene Soluble Implant MaterialCeremed, Inc.20110—
+3K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Ceremed, Inc.200828—
+3K082245Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LVCeremed, Inc.20080—
+4K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+4K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20221—
+4K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc.20212—
+4K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc.20160—
+4K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.20160—
+4K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC20160—
+4K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201512—
+4K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc.20140—
+4K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc.20121—
+4K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation20115Class I
+4K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC20110Class I
+4K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.200920—
+5K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.20260—
+5K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.20260—
+5K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+5K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20233—
+5K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc.20193—
+5K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc.20130—
+5K122156Orthocon Absorbable Hemostatic Bone PuttyOrthocon, Inc.20133—
+5K111524MP 719Marine Polymer Technologies, Inc.20110—
+5K102071Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.201017—
+6K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20231—
+6K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+6K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20201—
+6K140117Ahbppress Absorbable Hemostatic Bone PuttyOrthocon, Inc.20142—
+6K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc.20126—
+7K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20230—
+7K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC20140—
+7K121953Hemasorb ApplyOrthocon, Inc.20120—