510(k) Report

Devices descending from K000080

916 later devices reach Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+4K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+4K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+4K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+4K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+4K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+4K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+4K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+4K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+4K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253906Xpert HandNewclip Technics20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K253291Excelsior SystemBlue Ocean Global20260—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+5K253202Hoffmann LRF SystemStryker GmbH20250—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K251365OptumSI Implant SystemSi Solutions, LLC20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250647SImmetry+ SystemSivantage20250—
+5K242988Genostis Osteosynthesis SystemGenostis AF20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—