510(k) Report

Devices descending from K944561

450 later devices reach Micro Osteosynthesis System (1.0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+8K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K181091AxSOS 3 TiStryker GmbH201811—
+8K150359Tensyn PlugDallen Medical, Inc.20150—
+8K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+8K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+8K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+8K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+9K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+9K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+9K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+10K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+11K252246Leforte MMF SystemJeil Medical Corporation20260—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—