510(k) Report

Devices descending from K963192

581 later devices reach Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K210159IntraLock SystemFusion Orthopedics, LLC20210—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+6K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+6K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+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—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—