510(k) Report

Devices descending from K030198

678 later devices reach Hand Innovations, Inc. Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+7K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+7K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+7K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+7K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+7K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+7K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+7K221342REDEMPTION Beaming SystemVilex, LLC20220—
+7K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K202326BESPA Charcot SystemBespa Global, LLC20210—
+7K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+7K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+7K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K200062Foot and Ankle SystemLeith Medical, LLC20210—
+7K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+7K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+7K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+7K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+7K193368Smart Correction SystemWishbone Medical, Inc.202031
+7K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+7K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+7K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K193029Conquest FNSmith & Nephew, Inc.202010—
+7K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+7K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+7K190586Monster® Screw SystemParagon 28, Inc.201921—
+7K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+7K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+7K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+7K172785Conquest FNSmith & Nephew20178—
+7K172350AxSOS 3 TiStryker GmbH201717—
+7K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+7K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+7K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+7K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+7K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+7K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+7K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+7K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+7K152686Conquest FNSmith & Nephew201612—
+7K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+7K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+7K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+7K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+7K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+7K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+7K151418Monster Screw SystemParagon 28201527—
+7K142581APTUS Foot SystemMedartis AG201522—
+7K143365Eminent Foot Plate SystemEminent Spine20151—
+7K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+7K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+7K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+7K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+7K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+7K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+7K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+7K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+7K140376Variax 2 SystemStryker Trauma AG201423—
+7K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+7K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+7K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+7K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+7K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+7K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+7K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+7K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+7K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+7K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+7K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+7K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+8K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+8K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+8K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+8K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+8K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K253291Excelsior SystemBlue Ocean Global20260—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+8K253202Hoffmann LRF SystemStryker GmbH20250—
+8K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—