510(k) Report

Devices descending from K101536

75 later devices reach 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192984APTUS Clavicle SystemMedartis AG20206—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+1K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+1K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa)201145—
+2K260761APTUS Clavicle System 2.8Medartis AG20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K201321DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemDePuy Synthes202031
+2K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+3K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…DePuy Synthes20201—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K140769Variax 2 SystemStryker Trauma AG201419—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K180500VariAx 2 SystemStryker GmbH201812—
+6K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+7K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K233919VariAx 2 Distal Radius SystemStryker GmbH20242—