510(k) Report

Devices descending from K152062

11 later devices reach BIOFOAM Bone Wedge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172294Osteotomy Truss System (OTS)4Web, Inc.201810—
+2K220463Osteotomy Truss System (OTS)4Web Medical, Inc.20221—
+2K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+3K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+3K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+3K240388Osteotomy Truss System (OTS)4Web Medical, Inc.20240—
+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—