510(k) Report

Devices descending from K030336

16 later devices reach Kmedic External Fixation Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181898Two-Step Implant SystemTrilliant Surgical20180—
+1K121008Trilliant Surgical K-WiresTrilliant Surgical, Ltd.201271
+1K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+1K102215Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab20106—
+2K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+2K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+3K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+4K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+4K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—