510(k) Report

Devices descending from K962011

738 later devices reach Synthes 7.0/7.3 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+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—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K210159IntraLock SystemFusion Orthopedics, LLC20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193366T2 ICFStryker GmbH20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+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—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+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—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K242303MOD-COrthomod, LLC20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241539Activmotion SNewclip Technics20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—