510(k) Report

Devices descending from K962236

548 later devices reach Scarf Thread-Head Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+6K213214Xpert WristNewclip Technics20210—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+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—
+6K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193366T2 ICFStryker GmbH20201—
+6K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+6K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+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—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K173641Activ AnkleNewclip Technics20183—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170843Alians Fragment SpecificNewclip Technics20171—
+6K170771VariAx 2 Foot SystemStryker GmbH20170—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+6K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+6K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+6K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K262344Large Compression ScrewsTriMed, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K261241TriMed Compression ScrewsTriMed, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+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—
+7K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+7K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+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—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K191009Arsenal Plating SystemTrilliant Surgical20192—
+7K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+7K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—