510(k) Report

Devices descending from K944565

522 later devices reach KLS-Martin Micro Osteosythesis System (1.5MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+9K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+9K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+10K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+10K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+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—