510(k) Report

Devices descending from K011978

701 later devices reach Synthes LCP Proximal Tibia Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+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—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K190830TDM Screw SystemsTdm Co., Ltd.20191—
+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—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K173641Activ AnkleNewclip Technics20183—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K173135VariAx 2 SystemStryker GmbH201713—
+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—
+6K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+7K262344Large Compression ScrewsTriMed, Inc.20260—