510(k) Report

Devices descending from K131360

10 later devices reach Integra Titanium Bone Wedge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D20198—
+1K153207Additive Orthopaedics Bone Wedge SystemAdditive Orthopaedics, LLC20160—
+2K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+3K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+3K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+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—