510(k) Report

Devices descending from K983121

127 later devices reach Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+4K183228HammerToe Compression SystemParagon 28, Inc.20190—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+4K152710HammerFiX DeviceExtremity Medical, LLC20151—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+4K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+4K133520Hammerlock 2Biomedical Enterprises, Inc.20145—
+4K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+5K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+5K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC202002
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.20160—
+5K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+6K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+7K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—