510(k) Report

Devices descending from K170650

11 later devices reach Orthofix TrueLok Hexapod System (TL-HEX) V2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242861TrueLok ElevateOrthofix Srl20243—
+1K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+1K193368Smart Correction SystemWishbone Medical, Inc.202031
+1K173883External Fixation SystemLife Spine, Inc.20180—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+2K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+2K253291Excelsior SystemBlue Ocean Global20260—
+2K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+2K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+2K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+2K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—