510(k) Report

Devices descending from K960385

146 later devices reach Sterile Kirschner Wires and Steinmann Pins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140283Osteomed Extremifuse SystemOsteomed20140—
+3K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc.20137—
+3K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+3K130412Osteomed Extremifuse SystemOsteomed20134—
+3K122959Hammer Toe ImplantTrilliant Surgical, Ltd.2012221
+3K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+3K112197Memometal Intra-Medullary Bone FastenerMemometal Technologies201151
+4K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+4K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+4K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+4K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+4K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+4K201715Smart Toe II, X FuseStryker GmbH20201—
+4K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+4K183228HammerToe Compression SystemParagon 28, Inc.20190—
+4K152710HammerFiX DeviceExtremity Medical, LLC20151—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+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—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+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—
+5K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.20160—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—