510(k) Report

Devices descending from K001941

800 later devices reach Synthes Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+6K221342REDEMPTION Beaming SystemVilex, LLC20220—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K202326BESPA Charcot SystemBespa Global, LLC20210—
+6K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K200062Foot and Ankle SystemLeith Medical, LLC20210—
+6K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation20213—
+6K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+6K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+6K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+6K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+6K193368Smart Correction SystemWishbone Medical, Inc.202031
+6K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+6K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+6K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+6K193029Conquest FNSmith & Nephew, Inc.202010—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+6K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+6K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+6K190586Monster® Screw SystemParagon 28, Inc.201921—
+6K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+6K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+6K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+6K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+6K172785Conquest FNSmith & Nephew20178—
+6K172350AxSOS 3 TiStryker GmbH201717—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+6K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+6K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+6K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+6K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+6K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+6K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+6K152686Conquest FNSmith & Nephew201612—
+6K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+6K151418Monster Screw SystemParagon 28201527—
+6K142581APTUS Foot SystemMedartis AG201522—
+6K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+6K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+6K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+6K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+6K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+6K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+6K140376Variax 2 SystemStryker Trauma AG201423—
+6K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+6K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+6K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+6K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+6K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+6K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+6K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+6K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+7K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K260411PC Fix SystemChest Wall Innovations, Inc.20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K253291Excelsior SystemBlue Ocean Global20260—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K253202Hoffmann LRF SystemStryker GmbH20250—
+7K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+7K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+7K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+7K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—