510(k) Report

Devices descending from K971680

55 later devices reach Auto Suture Bone Wax through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201413—
+1K123243Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc.201316—
+1K111538Skaffold CisSkeletal Kinetics, LLC201118—
+1K111524MP 719Marine Polymer Technologies, Inc.20110—
+1K060987OSCERA7 Synthetic Absorbable Bone Wax, Model OS31Cp Medical20060—
+1K043260Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC200514—
+1K041363Aoc Bone WaxCeremed, Inc.2004521
+1K024372CP Medical Bone WaxCp Medical200329—
+2K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+2K200452Meril-BonewaxM/s. Meril Endo Surgery Private Limited.20230—
+2K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20221—
+2K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc.20212—
+2K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc.20160—
+2K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201512—
+2K142348OsteoSeal Bone HemostatHemostasis, LLC20150—
+2K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc.20140—
+2K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC20140—
+2K122156Orthocon Absorbable Hemostatic Bone PuttyOrthocon, Inc.20133—
+2K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc.20126—
+2K113627Hemasorb Resorbable Hemostatic Bone PuttyOrthocon20121—
+2K102762Orthostat Bone Hemostat Matrix ApplicatorOrthocon, Inc.20119—
+2K091121OrthostatOrthocon, Inc.200910—
+2K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc.200638—
+2K063330Orthocon Hemasorb Resorbable Hemostatic Bone PuttyOrthocon, Inc.20061—
+2K052528Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc.200539—
+2K050440Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12Ceremed, Inc.200540—
+2K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc.200543—
+3K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.20260—
+3K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.20260—
+3K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+3K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20233—
+3K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc.20193—
+3K140117Ahbppress Absorbable Hemostatic Bone PuttyOrthocon, Inc.20142—
+3K121953Hemasorb ApplyOrthocon, Inc.20120—
+3K081531Aoc Soluble Implant MaterialCeremed, Inc.20085—
+3K080507Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical ImplantCeremed, Inc.20089—
+3K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc.200729—
+4K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20231—
+4K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+4K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20201—
+4K120220Adaptain Soluble Implant MaterialCeremed, Inc.20122—
+4K111323Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc.20112—
+4K103047Ceretene Soluble Implant MaterialCeremed, Inc.20110—
+4K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Ceremed, Inc.200828—
+4K082245Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LVCeremed, Inc.20080—
+5K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20230—
+5K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC20160—
+5K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141—
+5K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc.20121—
+5K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation20115Class I
+5K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC20110Class I
+5K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.200920—
+6K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.20160—
+6K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc.20130—
+6K102071Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.201017—