510(k) Report

Devices descending from K140531

24 later devices reach Biofoam Bone Wedge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+1K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+1K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+1K150394Tyber Medical Wedge SystemTyber Medical, LLC20156—
+1K142724BIOFOAM Bone WedgeWrightmedicaltechnologyinc201520—
+2K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+2K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+2K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+2K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+2K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+2K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+2K171327Tyber Medical Wedge SystemTyber Medical, LLC20175—
+2K162241TITAN 3-D™ Wedge SystemParagon 28201721
+2K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+2K152062BIOFOAM Bone WedgeWrightmedicaltechnologyinc201611—
+3K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+3K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+3K231496TITAN 3-D Wedge SystemParagon 28, Inc.20230—
+3K172294Osteotomy Truss System (OTS)4Web, Inc.201810—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K220463Osteotomy Truss System (OTS)4Web Medical, Inc.20221—
+4K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+5K240388Osteotomy Truss System (OTS)4Web Medical, Inc.20240—