510(k) Report

Devices descending from K063049

468 later devices reach Synthes (Usa) Modular Mini Fragment LCP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+1K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K221920ARIX Small Fragment SystemJeil Medical Corporation20220—
+1K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+1K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+1K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+1K201656ARIX Elbow SystemJeil Medical Corporation20200—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K191344Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleArthrex, Inc.20198—
+1K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+1K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc.201845
+1K182466AOS Calcaneal Plating SystemAdvanced Orthopaedic Solutions20180—
+1K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+1K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K170771VariAx 2 Foot SystemStryker GmbH20170—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+1K143394Acumed Small Fragment Base SetAcumed, LLC201518—
+1K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+1K140724MSP Metatarsal Shortening SystemNextremity Solutions, Inc.20146—
+1K133536Emerge Medical Bone Plate SystemEmerge Medical20140—
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254—
+1K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+1K1133642.7MM LCP Ulna Osteotomy SystemSynthes (USA) Products, LLC201231
+1K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+1K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+1K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+1K103332Aptus Ulna PlatesMedartis AG201171—
+1K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+1K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+1K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K253906Xpert HandNewclip Technics20260—
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+2K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+2K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+2K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+2K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+2K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+2K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc.20200—
+2K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K173746Activmotion RangeNewclip Technics20181—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—