510(k) Report

Devices descending from K022599

118 later devices reach Newdeal K Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+4K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+4K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC202002
+4K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.20160—
+4K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+6K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—