510(k) Report

Devices descending from K063875

167 later devices reach Stryker Foot Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+1K192675VariAx FootStryker GmbH20190—
+1K161864ARIX Foot SystemJeil Medical Corporation20165—
+1K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+1K151769Anchorage 2 CP SystemStryker GmbH20150—
+1K141204Variax 2 One Third Tubular Plating SystemStryker Trauma AG20147—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K140376Variax 2 SystemStryker Trauma AG201423—
+1K132502Variax 2 SystemStryker Trauma AG201321—
+1K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+1K131311Arix Foot SystemJeil Medical Corporation20139—
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+2K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K151879VariAx 2 One-Third Tubular Plating SystemStryker GmbH20156—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K141992Variax 2 SystemStryker Trauma AG201422—
+2K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+2K140769Variax 2 SystemStryker Trauma AG201419—
+2K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+2K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+2K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+2K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K170771VariAx 2 Foot SystemStryker GmbH20170—
+3K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+3K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+3K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441