510(k) Report

Devices descending from K000684

965 later devices reach Small Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K151418Monster Screw SystemParagon 28201527—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+4K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+4K141401Easy OutFeet For Life Podiatry Center20150—
+4K141548High Tibial Osteotomy SystemNewclip Technics20153—
+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—
+4K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+4K130510Arthrex Compression PlatesArthrex, Inc.20138—
+4K130774Universal Distal Radius SystemNewclip Technics20135—
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K120903Congruent Bone Plate System: Acu-Loc 2 PlateAcumed, LLC20126—
+4K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+4K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+4K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC201281
+4K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+4K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+4K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+4K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+4K1032432.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa)2011187
+4K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+4K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+4K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+4K063831Basal Dorsal PlatesNewdeal Sas20070—
+4K060474Lisfranc PlateNew Deal, S.A.20061—
+4K060476Lapidus PlateNew Deal, S.A.20061—
+4K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+4K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+4K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+4K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253291Excelsior SystemBlue Ocean Global20260—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+5K253202Hoffmann LRF SystemStryker GmbH20250—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K252061Distal Xtremities SystemTriMed, Inc.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221412ARIX Rib SystemJeil Medical Corporation20221—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—