510(k) Report

Devices descending from K142724

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+1K162241TITAN 3-D™ Wedge SystemParagon 28201721
+1K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+1K152062BIOFOAM Bone WedgeWrightmedicaltechnologyinc201611—
+2K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+2K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+2K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+2K231496TITAN 3-D Wedge SystemParagon 28, Inc.20230—
+2K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+2K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+2K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+2K172294Osteotomy Truss System (OTS)4Web, Inc.201810—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+3K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+3K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+3K220463Osteotomy Truss System (OTS)4Web Medical, Inc.20221—
+3K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+3K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+4K240388Osteotomy Truss System (OTS)4Web Medical, Inc.20240—