510(k) Report

Devices descending from K950045

438 later devices reach KLS-Martin Mandibular Fracture/Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—