510(k) Report

Devices descending from K993106

728 later devices reach Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+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—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203381Dynanail Mini HybridMedShape, Inc.202141
+6K202810AutoStrut G2Orthospin, Ltd.20213—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K193366T2 ICFStryker GmbH20201—
+6K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K190830TDM Screw SystemsTdm Co., Ltd.20191—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K180500VariAx 2 SystemStryker GmbH201812—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170771VariAx 2 Foot SystemStryker GmbH20170—
+6K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+6K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+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—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+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—
+7K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+7K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+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—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K191009Arsenal Plating SystemTrilliant Surgical20192—
+7K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+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—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242861TrueLok ElevateOrthofix Srl20243—
+8K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—