510(k) Report

Devices descending from K030131

133 later devices reach Ossatura BCP Bone Void Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+5K193487Agilon StripBiogennix, LLC20200—
+5K193168Agilon MoldableBiogennix, LLC20200—
+5K192363AltaporeBaxter Healthcare Corporation20204—
+5K191513Altapore ShapeBaxter Healthcare Corporation20192—
+5K121177Bond ApatiteAugma Biomaterials, Ltd.20130—
+5K082463ProgenixMedtronic Sofamor Danek20080—
+5K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K233259XerosynXerothera, Inc.20240—
+6K201464Altapore MISBaxter Healthcare Corporation20201—
+6K200640Altapore ShapeBaxter Healthcare Corporation20201—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—