510(k) Report

Devices descending from K023007

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+10K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+10K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+10K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+10K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+10K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+10K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K251555Ultra™ Compression Screw SystemPace Surgical20251—
+10K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+10K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+10K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+10K241525ExcelsiusXR™Globus Medical, Inc.20250—
+10K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+10K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+10K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+10K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+10K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+10K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+10K240160EGPS Navigated InstrumentsAstura Medical20240—
+10K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+10K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+10K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+10K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+10K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+10K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+10K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+10K223558CUVIS-spineCurexo, Inc.20230—
+10K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+10K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+10K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+10K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+10K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+10K221395Footmotion Plating SystemNewclip Technics20220—
+10K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+10K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+10K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+10K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+10K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+10K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+10K201569CUVIS-spineCurexo, Inc.20212—
+10K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+10K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+10K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K203381Dynanail Mini HybridMedShape, Inc.202141
+10K202810AutoStrut G2Orthospin, Ltd.20213—
+10K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+10K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+10K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+10K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+10K193366T2 ICFStryker GmbH20201—
+10K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+10K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+10K190830TDM Screw SystemsTdm Co., Ltd.20191—
+10K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+10K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+10K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+10K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+10K173641Activ AnkleNewclip Technics20183—
+10K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+10K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+10K172886Breakaway Screw SystemParagon 2820174—
+10K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+10K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+10K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+10K170771VariAx 2 Foot SystemStryker GmbH20170—
+10K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+10K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+10K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+10K151769Anchorage 2 CP SystemStryker GmbH20150—
+10K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+10K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+11K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+11K262344Large Compression ScrewsTriMed, Inc.20260—
+11K261511Xpert AnkleNewclip Technics20260—
+11K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+11K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+11K261241TriMed Compression ScrewsTriMed, Inc.20260—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+11K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+11K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+11K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+11K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+11K242415TMC Compression Implant SystemTreace Medical Concepts20243—