510(k) Report

Devices descending from K993106

728 later devices reach Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+4K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+4K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+4K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+4K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+4K130774Universal Distal Radius SystemNewclip Technics20135—
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+4K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+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—
+4K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+4K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+4K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+5K262649Alians ForearmNewclip Technics20260—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253906Xpert HandNewclip Technics20260—
+5K253764ENOS Software Guided External Fixation SystemDisior, Ltd.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—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242988Genostis Osteosynthesis SystemGenostis AF20250—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+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—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—