510(k) Report

Devices descending from K994143

127 later devices reach Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+6K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.20250—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K242861TrueLok ElevateOrthofix Srl20243—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K232838Monkey RingsTM External Fixation SystemParagon 28, Inc.20233—
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+6K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+6K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—