510(k) Report

Devices descending from K141905

11 later devices reach Pro-Link Wedge System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+1K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+2K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+2K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+2K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+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—
+3K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+4K252254Osteotomy Wedge SystemSinaptic Surgical20250—