510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153379AxSOS 3TiStryker GmbH201625—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K153378Monster BITE Screw SystemParagon 28201522—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+5K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+5K143721PRCT2Fx Solutions20150—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K150871ForeFoot STP SystemTornier, Inc.20150—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+5K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+5K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+5K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+5K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+5K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+5K131061Restore Bunion Correction SystemNextremity Solutions201315—
+5K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+5K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+5K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+5K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+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—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+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—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+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—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, 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—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+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—
+6K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+6K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—