510(k) Report

Devices descending from K021883

116 later devices reach Biofastin RC Threaded Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+8K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+8K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+9K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+9K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+10K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+10K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+10K243658TMC Compression Implant SystemTreace Medical Concepts20242—