510(k) Report

Devices descending from K191047

8 later devices reach ADI TiDAL Osteotomy Wedge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+2K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+2K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+2K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+2K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+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—