510(k) Report

Devices descending from K021932

755 later devices reach Synthes 6.5 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+5K202307Activ FuseNewclip Technics20200—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190230iFuse Implant System®SI-BONE, Inc.201957—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—