510(k) Report

Devices descending from K051195

140 later devices reach Grafton DBM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K223915TactosetAnika Therapeutics, Inc.20231—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+5K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+5K190956SCS 17-01Anika Therapeutics, Inc.20203—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K130703Vivorte BVFVivorte, Inc.201311
+5K113049Socket GraftSteiner Laboratories20120—
+5K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+5K093447CarrigenEtex Corp.201021—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+6K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+6K182107CarriGen PFEtex Corporation20181—
+6K143547Vivorte Trabexus EBVivorte, Inc.201501
+6K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+6K102528N-Force Fixation SystemInnovision, Inc.20115—
+6K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+7K151146N-Force Fixation SystemInnovision, Inc.20151—
+7K142776Flow-ScrewFlow-Fx, LLC20151—
+7K132244N-Force Fixation SystemInnovision, Inc.20143—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—