510(k) Report

Devices descending from K101056

58 later devices reach Variax Elbow System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+1K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+1K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+1K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+1K132502Variax 2 SystemStryker Trauma AG201321—
+1K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+1K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K201656ARIX Elbow SystemJeil Medical Corporation20200—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+2K140769Variax 2 SystemStryker Trauma AG201419—
+2K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+2K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180500VariAx 2 SystemStryker GmbH201812—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—