510(k) Report

Devices descending from K012655

792 later devices reach Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+5K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+5K152686Conquest FNSmith & Nephew201612—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+5K151418Monster Screw SystemParagon 28201527—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+5K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+5K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+5K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+5K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+5K140376Variax 2 SystemStryker Trauma AG201423—
+5K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+5K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+5K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+5K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+5K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+5K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+5K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260411PC Fix SystemChest Wall Innovations, Inc.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253291Excelsior SystemBlue Ocean Global20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K253202Hoffmann LRF SystemStryker GmbH20250—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+6K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+6K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+6K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212552Correx SoftwareVilex, LLC20210—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210159IntraLock SystemFusion Orthopedics, LLC20210—
+6K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K210268LTJ Screws and WasherAzurmeds, Inc.20210—