510(k) Report

Devices descending from K151256

10 later devices reach Arthrex BioSync® 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—
+1K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+1K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+2K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+2K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+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—