510(k) Report

Devices descending from K220197

4 later devices reach Trigon HA Wedge Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+1K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+1K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+2K252254Osteotomy Wedge SystemSinaptic Surgical20250—