510(k) Report

Devices descending from K040598

360 later devices reach KLS Martin Hand Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+7K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+7K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+7K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+7K211843PolyLock Plating SystemFusion Orthopedics20220—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+7K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K191009Arsenal Plating SystemTrilliant Surgical20192—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K181091AxSOS 3 TiStryker GmbH201811—
+7K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+7K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+7K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+7K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+8K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+8K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+8K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+9K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+9K143092Tensyn PlugDallen Medical, Inc.20151—
+10K252246Leforte MMF SystemJeil Medical Corporation20260—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K150359Tensyn PlugDallen Medical, Inc.20150—