510(k) Report

Devices descending from K072160

108 later devices reach Nexgen Trabecular Metal Tibial Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—