510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150871ForeFoot STP SystemTornier, Inc.20150—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+3K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+3K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K131920Stabilization ScrewIn2bones Sas2014183
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+3K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+3K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+3K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K130954Ars Screw; Slant ScrewAdvanced Interventional Technology, LLC20130—
+3K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+3K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+3K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+3K092189Pogo ScrewFxdevices20091—
+3K091798Merete Compression ScrewsMerete Medical GmbH200926—
+3K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+3K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC20094—
+3K071639Qwix Positioning ScrewNewdeal Sas2007521
+3K040356Kompressor Screw SystemKinetikos Medical, Inc.2004255—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+4K253291Excelsior SystemBlue Ocean Global20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+4K253202Hoffmann LRF SystemStryker GmbH20250—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242988Genostis Osteosynthesis SystemGenostis AF20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—