510(k) Report

Devices descending from K130185

14 later devices reach 4WEB Osteotomy Bone Wedge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+1K220463Osteotomy Truss System (OTS)4Web Medical, Inc.20221—
+1K172294Osteotomy Truss System (OTS)4Web, Inc.201810—
+1K162241TITAN 3-D™ Wedge SystemParagon 28201721
+1K153207Additive Orthopaedics Bone Wedge SystemAdditive Orthopaedics, LLC20160—
+2K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+2K240388Osteotomy Truss System (OTS)4Web Medical, Inc.20240—
+2K231496TITAN 3-D Wedge SystemParagon 28, Inc.20230—
+2K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+3K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+4K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+4K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—