510(k) Report

Devices descending from K982222

716 later devices reach Synthes (Usa) Distal Femur Plate (DFP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+6K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K153378Monster BITE Screw SystemParagon 28201522—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K150871ForeFoot STP SystemTornier, Inc.20150—
+6K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+6K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K150626Rush Medullary PinsZimmer, Inc.20150—
+6K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+6K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+6K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+6K140769Variax 2 SystemStryker Trauma AG201419—
+6K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+7K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K251555Ultra™ Compression Screw SystemPace Surgical20251—
+7K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203381Dynanail Mini HybridMedShape, Inc.202141
+7K202810AutoStrut G2Orthospin, Ltd.20213—
+7K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200226RetroFixRetrofix Screws, LLC20200—