510(k) Report

Devices descending from K100271

80 later devices reach Vari AX Distal Radius Line Extensions of XXL Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+1K132502Variax 2 SystemStryker Trauma AG201321—
+1K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+1K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+2K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K140769Variax 2 SystemStryker Trauma AG201419—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+4K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K180500VariAx 2 SystemStryker GmbH201812—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K191972ARIX Wrist SystemJeil Medical Corporation20190—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—