510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211843PolyLock Plating SystemFusion Orthopedics20220—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation20213—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203381Dynanail Mini HybridMedShape, Inc.202141
+6K202810AutoStrut G2Orthospin, Ltd.20213—
+6K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+6K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+6K193366T2 ICFStryker GmbH20201—
+6K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+6K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K190830TDM Screw SystemsTdm Co., Ltd.20191—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+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
+6K172350AxSOS 3 TiStryker GmbH201717—
+6K162171S4 Screw System™Subchondral Solutions20173—
+6K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+6K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+6K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+6K170771VariAx 2 Foot SystemStryker GmbH20170—
+6K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+6K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+6K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+6K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+6K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K260411PC Fix SystemChest Wall Innovations, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+7K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+7K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+7K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+7K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K231860TDM Screw SystemTdm Co., Ltd.20240—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+7K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+7K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+7K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+7K210159IntraLock SystemFusion Orthopedics, LLC20210—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+7K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+7K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+7K181091AxSOS 3 TiStryker GmbH201811—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+7K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+7K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—