510(k) Report

Devices descending from K051605

27 later devices reach Sbi K-Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.20200—
+1K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+1K141401Easy OutFeet For Life Podiatry Center20150—
+1K122777NBX - Non Bridging External Fixator HandNutek Orthopaedics, Inc.20130—
+1K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+1K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+2K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—