510(k) Report

Devices descending from K043421

16 later devices reach Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151271BellaFuseHans Biomed Corp.20160—
+1K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+1K061668Optecure +CCCExactech, Inc.20062—
+1K051047Colloss E Bone Void FillerOssacur AG20060—
+2K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+2K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+2K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+2K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+3K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+3K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+3K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+4K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—