510(k) Report

Devices descending from K032705

615 later devices reach Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+7K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+7K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+7K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+7K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+7K153378Monster BITE Screw SystemParagon 28201522—
+7K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+7K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+7K150871ForeFoot STP SystemTornier, Inc.20150—
+7K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+7K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+7K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+7K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+7K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+7K141992Variax 2 SystemStryker Trauma AG201422—
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+7K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+7K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+8K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+8K261191Alians Elbow SNewclip Technics20260—
+8K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+8K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+8K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+8K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+8K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K251555Ultra™ Compression Screw SystemPace Surgical20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+8K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+8K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+8K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+8K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+8K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230204ALPHALOK Plating SystemVilex, LLC20230—
+8K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+8K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+8K221558ALPHALOK Plating SystemVilex, LLC20222—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K221395Footmotion Plating SystemNewclip Technics20220—
+8K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+8K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+8K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+8K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203381Dynanail Mini HybridMedShape, Inc.202141
+8K202810AutoStrut G2Orthospin, Ltd.20213—
+8K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+8K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200226RetroFixRetrofix Screws, LLC20200—
+8K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+8K193366T2 ICFStryker GmbH20201—
+8K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+8K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+8K190830TDM Screw SystemsTdm Co., Ltd.20191—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—