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
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+2K132244N-Force Fixation SystemInnovision, Inc.20143—
+2K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+2K131764Acumed Wrist Spanning PlateAcumed, LLC20137—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K130009Variax 2 Compression Plating SystemStryker Trauma AG2013271
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+2K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+2K113718NCB Straight Narrow Shaft PlatesZimmer GmbH201271
+2K112926Axsos Locking Plate SystemStryker Corp.20110—
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+2K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+2K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa)200951—
+2K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K090440Hinge Pediatric Plating SystemPega Medical, Inc.20091—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+2K080649Pogo ScrewFxdevices200815—
+2K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+2K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+2K063487Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH2007257—
+2K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+2K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+2K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+2K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+2K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+2K050457Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH2005258—
+2K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261511Xpert AnkleNewclip Technics20260—
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+3K243469SignexOsteonic Co., Ltd.20250—
+3K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+3K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+3K241942TriMed Bridge PlatesTriMed, Inc.20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K220190The GIRO Growth Modulation SystemPega Medical, Inc.20220—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+3K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K213572JuniOrtho Plating System™Orthofix Srl20220—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K213214Xpert WristNewclip Technics20210—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+3K202307Activ FuseNewclip Technics20200—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+3K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—