510(k) Report

Devices descending from K110069

18 later devices reach Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+1K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+1K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+1K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+2K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+2K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+2K212552Correx SoftwareVilex, LLC20210—
+2K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K173883External Fixation SystemLife Spine, Inc.20180—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K253202Hoffmann LRF SystemStryker GmbH20250—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+3K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+3K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+3K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—