510(k) Report

Devices descending from K050636

544 later devices reach Synthes 3.0MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213214Xpert WristNewclip Technics20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K202810AutoStrut G2Orthospin, Ltd.20213—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193366T2 ICFStryker GmbH20201—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K173641Activ AnkleNewclip Technics20183—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+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—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+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—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+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—
+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—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+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—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+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—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+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—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+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—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242861TrueLok ElevateOrthofix Srl20243—
+7K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—