510(k) Report

Devices descending from K961421

462 later devices reach Synthes 2.4 MM Universal Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+9K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+9K233017TM Plating SystemTyber Medical, LLC20231—
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+9K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+9K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+9K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+9K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+9K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+9K211843PolyLock Plating SystemFusion Orthopedics20220—
+9K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+9K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+9K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+9K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+9K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K191009Arsenal Plating SystemTrilliant Surgical20192—
+9K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+9K181091AxSOS 3 TiStryker GmbH201811—
+9K150359Tensyn PlugDallen Medical, Inc.20150—
+9K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+9K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+9K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+9K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+10K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+10K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+10K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+10K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+10K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+10K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+10K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+10K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+10K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+10K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+10K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+10K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+11K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+11K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+11K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+12K252246Leforte MMF SystemJeil Medical Corporation20260—
+12K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—