510(k) Report

Devices descending from K903810

889 later devices reach Ace Cannulated Self Tapping Cancellous Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+4K170697GBR systemSurgident20182—
+4K173752SI Screw SystemZavation Medical Products, LLC20180—
+4K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K170475SICAGE™ SystemSicage, LLC20170—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+4K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K161864ARIX Foot SystemJeil Medical Corporation20165—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+4K143730GBR SystemJeil Medical Corporation20152—
+4K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+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
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+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—
+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—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+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—
+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—