510(k) Report

Devices descending from K060736

531 later devices reach Smith & Nephew 6.5MM and 8.0MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170843Alians Fragment SpecificNewclip Technics20171—
+5K170771VariAx 2 Foot SystemStryker GmbH20170—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+5K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K151769Anchorage 2 CP SystemStryker GmbH20150—
+5K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+5K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+6K231860TDM Screw SystemTdm Co., Ltd.20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K191009Arsenal Plating SystemTrilliant Surgical20192—
+6K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242861TrueLok ElevateOrthofix Srl20243—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—