510(k) Report

Devices descending from K060613

341 later devices reach Variax Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+1K091619Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)Anglefix20090—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+2K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+2K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+2K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+2K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+3K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K161448Footmotion Plating SystemNewclip Technics20165—
+3K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+3K153379AxSOS 3TiStryker GmbH201625—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+3K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+3K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+3K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+3K141905Pro-Link Wedge SystemLife Spine201411—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242988Genostis Osteosynthesis SystemGenostis AF20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—