510(k) Report

Devices descending from K013072

137 later devices reach Chronos Tricalcium Prosphate (Chronos TCP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+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—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K182107CarriGen PFEtex Corporation20181—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K143547Vivorte Trabexus EBVivorte, Inc.201501
+5K130977Signify BioactiveGlobus Medical, Inc.20131—
+5K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+5K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+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—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—